America’s Unsafe Medical Products

November 22, 2019 by Paul Ausick

The U.S. Food and Drug Administration (FDA) issued seven new safety alerts in the past week, one safety communication and six product recalls, four of which are related to ranitidine, the generic version of Xantac.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products, including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all Medwatch alerts for 2019 through November 19, 2019. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The most serious alert is a Class I recall, indicating that continued use of these devices may cause serious injury or death. The 2019 alerts are listed in reverse chronological order, with the most recent listed first. Included are the type of alert and the issue date.

Ranitidine Antacid Medication Recalled
> Issue date: November 19, 2019
> Type of alert: Recall

Precision Dose voluntarily recalling five lots of Ranitidine Oral Solution, USP 150 mg/10 mL that may be contaminated with excess levels of a carcinogen known as NDMA.

Device Failure Associated With Aortic Balloon Pumps
> Issue date: November 19, 2019
> Type of alert: Letter to health care providers

The FDA had issued a follow-up notice to health care providers regarding the failure of Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. More than 60 additional reported failures have occurred since the original November 1 warning, and two patients have died and another suffered serious injury.

Ranitidine Antacid Medication Recalled
> Issue date: November 15, 2019
> Type of alert: Recall

Golden State Medical Supply is voluntarily instituting a recall of all quantities and lots of Ranitidine HCl 150 mg and 300 mg capsules because of the potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

Male Enhancement Drug May Contain an Undeclared Ingredient
> Issue date: November 13, 2019
> Type of alert: Recall

Nature’s Rx is voluntarily recalling one lot of Silver Bullet (10 male enhancement capsules) that FDA inspectors found to contain undeclared sildenafil (Viagra). The drug may pose serious health risks to consumers with underlying medical issues like diabetes, high blood pressure or heart disease.

Ranitidine Antacid Medication Recalled
> Issue date: November 12, 2019
> Type of alert: Recall

Amneal Pharmaceuticals is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg and Ranitidine Syrup (Ranitidine oral solution, USP), 15 mg/mL because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Dietary Supplement May Be Tainted With Undeclared Ingredient
> Issue date: November 8, 2019
> Type of alert: Recall

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement may be tainted with undeclared sildenafil (Viagra).

Ranitidine Antacid Medication Recalled
> Issue date: November 8, 2019
> Type of alert: Recall

American Health Packaging is voluntarily recalling eight lots of ranitidine syrup (Ranitidine oral solution USP) 150 mg/10 mL Liquid Unit Dose Cups due to the detection of trace amounts of NDMA found in the finished drug product.

Ranitidine Antacid Medication Recalled
> Issue date: November 8, 2019
> Type of alert: Recall

Aurobindo Pharma USA is voluntarily recalling one lot of its ranitidine 150 mg tablets and 37 lots of Ranitidine 150 mg and 300 mg capsules and ranitidine syrup 15 mg/mL. A carcinogen known as NDMA has been detected in the finished products.

Software Issue With Robotic Surgery Arm
> Issue date: November 7, 2019
> Type of alert: Recall

The Zimmer Biomet ROSA Brain robotic platform that neurosurgeons use in positioning medical instruments or implants during surgery has been recalled to fix a software issue that may lead to mispositioning the robotic arm. A total of 86 devices were sold in the United States between April 8, 2016, and March 19, 2019. The FDA has identified this as a Class I recall.

Camera System May Fall, Crushing Patients
> Issue date: November 7, 2019
> Type of alert: Recall

Phillips Medical Systems (Cleveland) is recalling 852 nuclear-imaging Forte Gamma Camera Systems used to create images of the inside of patients’ bodies. A mechanical failure could cause the 660-pound detector to detach and fall on the patient. The FDA has identified this as a Class I recall.

Biotin (Vitamin B7) May Interfere With Some Lab Tests
> Issue date: November 5, 2019
> Type of alert: Safety communication

Biotin, also known as vitamin B7, is a dietary supplement that can interfere with certain lab tests and give false positive or negative readings. The FDA is reminding health care providers and patients that the agency is especially concerned about falsely low readings for troponin, “a clinically important biomarker to aid in the diagnosis of heart attacks, which may lead to a missed diagnosis and potentially serious clinical implications.”

Cybersecurity Risk for Insulin Pump
> Issue date: November 5, 2019
> Type of alert: Recall

Medtronic is recalling 1,117 insulin pumps that could allow unauthorized access to the device, instructing the pump “to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death.” The FDA has identified this as a Class I recall.

Circulatory Support Motor May Slow Down or Stop
> Issue date: November 6, 2019
> Type of Alert: Recall

Abbott is recalling 381 CentriMag Acute Circulatory Support Systems that may slow down or stop, putting the patient at risk of service adverse health consequences such as stroke, severe organ damage or death. The FDA has identified this as a Class I recall.

Potentially Nonsterile Topical Anesthesia Recalled
> Issue date: November 1, 2019
> Type of alert: Recall

Fagron is voluntarily recalling all unexpired lots of its Lets Gel Kit convenience packs due to contaminants found in some samples.

Particulate Matter in Hospital Injections
> Issue date: October 30, 2019
> Type of alert: Recall

ICU Medical is voluntarily recalling one lot of its lactated Ringer’s injection and one lot of 0.9% sodium chloride injection due to the presence of particulate matter. The injections are used for parenteral replacement of extracellular losses of fluid and electrolytes.

Stapling Device May Release Malformed Staples
> Issue date: October 30, 2019
> Type of alert: Recall

Ethicon is recalling four models of its Echelon Flex 60 stapler/articulating endoscopic linear cutter due to a flaw that may result in malformed staples. This is a Class 1 recall of 8,256 devices distributed in the United States between August 1 and September 26, 2019. To date, Ethicon has received reports of seven serious injuries and one death related to the faulty devices.

Risk of Leaks From Endovascular Grafts
> Issue date: October 28, 2019
> Type of alert: Safety communication

The FDA continues to evaluate new information related to blood leaking into an aneurysm following an Endologix AFS endovascular graft using certain materials. The agency recommends lifelong treatment for patients treated with any endovascular graft and is “emphasizing the importance of at least yearly, lifelong follow-up” for patients with Endologix AFX grafts.


Possible Contamination in Anxiety Disorder Drug
> Issue date:

October 26, 2019
> Type of alert: Recall

Mylan Pharmaceuticals is recalling one lot of Alprazolam tablets due to potential contamination. The drug is used to manage anxiety disorder, the short-term relief of symptoms of anxiety and the treatment of panic disorder, with or without agoraphobia.

Ranitidine Antacid Medication Recalled
> Issue date: October 25, 2019
> Type of alert: Recall

Lannett is voluntarily recalling all of its ranitidine syrup. The products may be contaminated with a carcinogen known as NDMA.

Ranitidine Antacid Medication Recalled
> Issue date: October 25, 2019
> Type of alert: Recall

Novitium Pharma is voluntarily recalling all quantities and lots of ranitidine hydrochloride capsules in the United States. The products may be contaminated with a carcinogen known as NDMA.

Heartburn Reliever Recalled
> Issue date: October 23, 2019
> Type of alert: Recall

Perrigo is voluntarily recalling all its ranitidine over-the-counter products sold in the United States. The products may be contaminated with a carcinogen known as NDMA.

Heartburn Reliever Recalled
> Issue date: October 23, 2019
> Type of alert: Recall

Dr. Reddy’s Laboratories is voluntarily recalling all Dr. Reddy’s ranitidine over-the-counter products sold in the United States. The products may be contaminated with a carcinogen known as NDMA.

Heartburn Reliever Recalled
> Issue date: October 23, 2019
> Type of alert: Recall

Sanofi is voluntarily recalling all Zantac (ranitidine) over-the-counter tablets sold in the United States. The products may be contaminated with a carcinogen known as NDMA.

Dietary Supplement for Male Sexual Enhancement Recalled
> Issue date: October 22, 2019
> Type of alert: Recall

GL Holdings is voluntarily recalling six lots of its Green Lumber 2-, 4- and 10-capsule packets that may be tainted with tadalafil, a prescription-only product that may be a risk to consumers who also take medications containing nitrates.

Baby Powder Recalled
> Issue date: October 18, 2019
> Type of alert: Recall

Johnson & Johnson voluntarily recalled a single lot of its Johnson’s Baby Powder in response to an FDA Test indicating that sub-trace levels of chrysotile asbestos (no more than 0.00002%) were found in a single bottle purchased from an online retailer.

Improperly Printed Product Information
> Issue date: October 16, 2019
> Type of alert: Product information

CSL Behring alerted customers to misprinted information on its folding box of Humate-P. The expiration date may not be printed in the proper location. See the MedWatch alert for photos of the incorrect and correct labeling.

Certain Injectable Products May Not Be Sterile
> Issue date: October 15, 2019
> Type of alert: Recall

Viatrexx Bio is voluntarily recalling 10 mL sterile injectable units of several products. The company cannot guarantee that the products are sterile.

Compounded Drugs May Not Be Sterile
> Issue date: October 10, 2019
> Type of alert: Recall

Innoveix Pharmaceuticals is voluntarily recalling all its sterile compounded drug products due to a lack of assurance of sterility. The affected products are injectable human chorionic gonadotropin (HCG) and injectable sermorelin w/GHRP2.

Infusion Sets May Leak Fluid Out of Air Vents
> Issue date: October 8, 2019
> Type of alert: Recall

ICU Medical is voluntarily recalling certain lots of its Plum and Sapphire Microbore Infusion sets due the potential for small amounts of fluid to leak out of the inline filter air vents.

Catheter Used in Vascular Systems at Risk of Separating and Detaching Fragments
> Issue date: October 8, 2019
> Type of alert: Recall

Medtronic is recalling 106,298 6 French Sherpa NX Active Guide Catheters in which the outer material may separate from the device that could result in detached fragments exposing the underlying stainless-steel braid. This is an FDA Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Update on Lung Injury Due to Vaping
> Issue date: October 4, 2019
> Type of alert: Safety communication

As of the issue date, the FDA had received more than 1,000 reports of lung injuries, including some that resulted in deaths, following the use of vaping devices. As of October 8, the Centers for Disease Control and Prevention (CDC) reported that it had received 1,299 reports of such lung injuries of which 26 ended in the death of the patient. Most patients report using THC-containing products (THC is the psychoactive ingredient in marijuana) and many states have temporarily stopped the sales of these products.

Cybersecurity Vulnerabilities Tied to Using Certain Medical Devices
> Issue date: October 1, 2019
> Type of notice: Safety communication

Security researchers have identified 11 cybersecurity vulnerabilities called Urgent/11 that could allow anyone to take control of certain medical devices from a remote location. Once control is established, the device’s function may be changed, a denial of service could occur or information or logical flaws could be introduced to prevent the device from functioning.

Skin Prep Lotion That Enhances Electrode Signal Quality Recalled
> Issue date: September 26, 2019
> Type of notice: Recall

Mavidon is voluntarily recalling 21 lots of LemonPrep 4-ounce tubes and single-use cups that may be contaminated with Burkholderia cepacia, a multi-drug-resistant pathogen that could cause serious infections and may be life-threatening for patients with compromised immune systems.

Impurity Found in Anti-Acid Medicine
> Issue date: September 25, 2019
> Type of notice: Recall

Apotex is voluntarily recalling its ranitidine Tablets (75 mg and 150 mg in all pack sizes and formats). The FDA and other global regulators have found that some ranitidine anti-acid medicines may contain an impurity that has been classified as a possible human carcinogen.

Potential Leakage in Infusion Pump
> Issue date: August 28, 2019 (added to Medwatch in late September)
> Type of notice: Recall

B. Braun Medical is voluntarily recalling one lot of its Infusomat Space Volumetric Infusion Pump Administration Set that may leak and/or disconnect at the bonded joint between the tubing and injection site. A total of 2,580 units manufactured in September 2018 were distributed between November 23, 2018 and March 20, 2019.

Impurity Found in Anti-Acid Medicine
> Issue date: September 23, 2019
> Type of notice: Recall

Sandoz is voluntarily all quantities and lots of ranitidine hydrochloride capsules in the United States. The FDA and other global regulators have found that some ranitidine anti-acid medicines may contain an impurity that has been classified as a possible human carcinogen.

Expanded Recall of Hypertension Medicine
> Issue date: September 19, 2019
> Type of notice: Recall

Torrent Pharmaceuticals is expanding its recall of losartan potassium/hydrochlorothiazide tablets due to the detection of trace amounts of an unexpected impurity.

Dietary Supplement Recalled
> Issue date: September 16, 2019
> Type of notice: Recall

Fitoterapia USA is voluntarily recalling 19,000 bottles of its Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement. The FDA found the product to be tainted with tadalafil, an FDA-approved prescription drug used to treat male erectile dysfunction. The presence of tadalafil in Macho is unapproved for safety and efficacy and is subject to recall.

Severe Lung Inflammation in Some Patients Being Treated for Breast Cancer
> Issue date: September 13, 2019
> Type of alert: Safety communication

Some breast cancer patients being treated with Ibrance (palbociclib), Kisqali (ribociclib) and Verzenio (abemaciclib) have experienced severe lung inflammation. The FDA has approved new warnings of this risk and noted that the overall benefit of the drugs remains greater than the risks when used as prescribed.

Impurity Found in Some Anti-Acid Medicine
> Issue date: September 12, 2019
> Type of alert: Safety information

Some ranitidine medicines, including Zantac, may contain an impurity that has been classified as a possible human carcinogen. The FDA recommends that patients taking prescription ranitidine talk to their doctors about an alternative and further recommends that over-the-counter users should consider other similarly available medicines.

Label Mix-Up Leads to Recall of Compounding Drug
> Issue date: September 12, 2019
> Type of alert: Recall

Darmerica is voluntarily recalling two lots of mislabeled quinacrine dihydrochloride. Due to a label mix-up, bottles labeled as containing quinacrine contain artemisinin.

Human and Animal Drugs Recalled Due to Lack of Assurance of Sterility
> Issue date: September 12, 2019
> Type of alert: Recall

KRS Global Biotechnology is recalling all lots of human and animal drugs distributed nationwide that may not be sterile. The products and lot numbers are listed at the FDA’s website.

IV Bags May Leak and Cause Serious Infection
> Issue date: September 10, 2019
> Type of alert: Recall

The Metrix Company of Dubuque, Iowa, is recalling specific lots of empty IV bags sold under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix brands. The bags could leak, resulting in a serious infection to the patient.

Milk of Magnesia Products Recalled
> Issue date: September 9, 2019
> Type of alert: Recall

Plastikon Healthcare is voluntarily recalling two lots of its milk of magnesia 2400 mg/30 mL oral suspension because the products did not meet the company’s own specification for total aerobic microbial count. The product is packaged and sold to institutions.

Bacteriostatic Water May Not Be Sterile
> Issue date: September 6, 2019
> Type of alert: Recall

Hospira, a division of Pfizer, is recalling one lot of its bacteriostatic water for injection due to lack of confirmation of sterility. The product is to be used only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection.

Protection Against Illnesses Caused by Vaping
> Issue date: September 6, 2019
> Type of alert: Consumer information

The FDA continues to try to determine the cause of illnesses and deaths related to using e-cigarettes (vaping). This information release specifically encourages “consumers to help protect themselves and avoid buying vaping products of any kind on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.” THC is the psychoactive ingredient in marijuana.

Parathyroid Hormone Injection Recalled
> Issue date: September 5, 2019
> Type of alert: Recall

Takeda Pharmaceutical is recalling all U.S. doses of its injectable Natpara (parathyroid hormone) drug due to potential for small rubber fragments to detach and fall into the cartridge.

Severe Respiratory Disease Associated With E-Cigarette Product
> Issue date: August 30, 2019
> Type of alert: Safety communication

The FDA reported that 215 possible cases and other reports of pulmonary illness related to e-cigarette product use had been filed with the agency. The FDA and the U.S. Centers for Disease Control (CDC) have ramped up investigations into the use of these products.

Hepatitis C Drugs May Worsen Liver Function
> Issue date: August 28, 2019
> Type of alert: Safety communication

Three drugs (Mavyret, Sepatier and Vosevi) used to treat chronic hepatitis C patients with moderate to severe liver impairment have resulted in rare cases of worsening liver function or liver failure.

Compounded Drug Products Recalled
> Issue date: August 27, 2019
> Type of alert: Recall

The FDA is requesting a recall of certain compounded drugs made by Pacifico National, doing business as AmEx Pharmacy, that “pose unnecessary risks due to significant quality and sterility concerns.”

Heart Valve System Recalled
> Issue date: August 22, 2019
> Type of alert: Recall

Edwards Lifesciences is recalling 1,585 Sapien 3 Ultra delivery systems that are part of the company’s Sapien 3 Transcatheter Heart Valve System used to replace a diseased aortic valve without open-heart surgery. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.” As of the end of July, Edwards had received reports of 17 injuries and one death related to the system.

Migraine Medication May Be Contaminated
> Issue date: August 15, 2019
> Type of alert: Recall

Pfizer is voluntarily recalling two lots of its Relpax 40 mg tablets that may not meet the company’s in-house microbiological specification for the presence of two contaminants.

Dangerous and Potentially Life-Threatening Side Effects of Miracle Mineral Solution
> Issue date: August 12, 2019
> Type of alert: Product warning

The FDA is warning consumers not to purchase or drink Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, Water Purification Solution (WPS) and other similar products. These products are promoted on social media as treatments for autism, cancer, HIV/AIDS, and other diseases but are not FDA-approved for any use.

No Increase of Prostate Cancer to Patients Using Certain Medicines to Treat Parkinson’s Disease
> Issue date: August 13, 2019
> Type of alert: Safety communication

Following additional review, the FDA found no increased risk of prostate cancer in patients using Comtan and Stalevo, both of which contain entacapone, for treating Parkinson’s disease.

Infusion Pump Recalled
> Issue date: August 12, 2019
> Type of alert: Recall

The Volumat MC Agilia Infusion System made by Fresenius Kabi is being recalled to change an alarm from low priority to high priority when the infusion is complete. The company is also making corrections to other issues in its software library. This is a Class I recall for 9,461 infusion pumps and 83 drug software libraries.

Microbiological Contamination in Topical Anesthetic Used Before Applying a Tattoo
> Issue date: August 8, 2019
> Type of alert: Recall

Ridge Properties DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products following an FDA analysis that found both microbiological contamination and higher-than-labeled potency.

Endotracheal Tube Connection May Fail
> Issue date: August 8, 2019
> Type of alert: Recall

Teleflex has informed Centurion of a recall of selected Sheridan Endotracheal Tubes and Connectors included in a kit. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.” Teleflex has received reports of four deaths and 18 injuries related to the recalled devices.

Treatment of Peripheral Arterial Disease With Balloons and Stents That Increase Mortality Risk
> Issue date: August 7, 2019
> Type of alert: Letter to health care providers

The FDA has reported that devices such as balloons and stents coated with paclitaxel raised the mortality risk for patients five years after being treated with the device by 57%. The report follows a January letter notifying health care providers of increased risk after two years and a March update noting an increased risk of mortality in five years.

Electrical Failure in Implantable Cardioverter Defibrillators
> Issue date: August 5, 2019
> Type of alert: Recall

Abbot (formerly St. Jude Medical) is recalling 108 Ellipse Implantable Cardioverter Defibrillators that have a manufacturing flaw in the wire leads that could lead to an electrical short. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.” The devices were manufactured between April 5 and May 29 of this year and distributed between May 6 and June 14.

Potential Leak in Pipette Filters
> Issue date: August 2, 2019
> Type of alert: Recall

A manufacturing problem has led to the recall of nearly 1.3 million filter-tips for the Qiagen QIAsymphony SP/AS instruments used in clinical assay workflows or with in vitro diagnostic tests. The flawed filter-tips may yield delayed or inaccurate results, including false positives, false negatives or incorrect counts. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

FDA Requests Recall of Textured Breast Implants
> Issue date: July 31, 2019
> Type of alert: Safety communication

The FDA has requested that Allergan recall all its Biocell textured breast implants and tissue expanders due to increased risk of breast implant-associated anaplastic large cell lymphoma. Allergan has agreed to the recall and has begun removing the products from global markets.

Higher Risk of Blood Clots Among Patients Using Xeljanz to Treat Ulcerative Colitis
> Issue date: July 26, 2019
> Type of alert: Safety communication

The FDA has approved new box warnings related to an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz XR (tofacitinib) used to treat patients with ulcerative colitis. The FDA noted that patients should not stop taking the drug before talking to their health care provider, “as doing so can worsen your condition.”

Herbal Products Marketed Without FDA Approval
> Issue date: July 24, 2019
> Type of alert: Recall

Herbal Doctor Remedies is voluntarily recalling all drug products. All have been marketed without FDA approval and manufactured outside required controls. The products were intended to be used as Chinese herbal medicines.

Oral Contraceptive’s Effectiveness May Be Compromised
> Issue date: July 23, 2019
> Type of alert: Recall

Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of its oral contraceptive for women Drospirenone and Ethinyl Estradiol tablets, USP, 3 mg/ 0.02mg in 28×3 blister pack/carton packaging. Product efficacy may be decreased due to decreased absorption of the active ingredients.

Intra-Aortic Balloon Pumps May Stop Unexpectedly
> Issue date: July 23, 2019
> Type of alert: Recall

The Maquet/Datascope balloon pump is used to assist patients during certain kinds of surgery or to treat those with acute coronary syndrome or complications from heart failure. The recalled pump’s battery may fail to hold a charge and stop working when used on battery power only. Five patients have died since March 2016, although the company has not concluded that the deaths were due solely to a malfunctioning device.

Mislabeled Hemophilia Treatment Recalled
> Issue date: July 19, 2019
> Type of alert: Recall

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials that may contain instead Bayer’s Jivi FVIII hemophilia A treatment. Patients in possession of vials from the affected lot numbers should immediately stop using the product and contact their physician.

Infusion Pump Tube Collapses
> Issue date: July 18, 2019
> Type of alert: Recall

Becton Dickinson has recalled Alaris infusion sets used to deliver fluids including blood and medications to patients. The devices could potentially deliver the fluid faster than expected or even deliver unintended doses. The company is recalling more than 151 million of the devices distributed in the United States between July 1, 2016, and April 18, 2019.

Neonatal/Infant Ventilation Device May Leak
> Issue date: July 17, 2019
> Type of alert: Recall

The Neonatal ConchaSmart Breathing Circuit is a mechanical ventilating device that hospitals use to deliver breathing assistance or general medical gases newborns and infants. Teleflex is recalling the devices due to reports of cracks that may cause the gas to leak and not reach the patient, which could lead to adverse consequences, including death. Teleflex delivered 300 of the recalled devices to U.S. health care facilities between December 2018 and January 2019. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Magnetic Interference Between Certain Implanted Devices
> Issue date: July 16, 2019
> Type of alert: Letter to health care providers

The FDA is notifying health care providers that possible magnetic interactions between cerebrospinal fluid (CSF) shunt systems and some hearing implants that contain magnets may lead to unintended changes in the programmable CSF shunt valve settings causing overdrainage or underdrainage of CSF. Patients could experience a variety of symptoms, including headaches, and if the symptoms are not treated can progress to loss of consciousness or even death.

Hospital Infant Warmers May Break
> Issue date: July 12, 2019
> Type of alert: Recall

GE Healthcare is recalling its Giraffe Warmers and Panda iRes Warmers used by hospitals and clinicians to care for infants. The company has notified its hospital customers and will replace all cracked or damaged panels and latches on the warmers at no cost. This alert is an update of one issued in June and lists model numbers for the devices. GE has received 338 complaints related to this problem and had shipped more than 25,000 of the devices between October 2007 and February 2019. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Faulty Software in Ventilator
> Issue date: July 12, 2019
> Type of Alert: Recall

The Hamilton-G5 ventilator sporadically displays an error message that communication between the device and its control panel has been lost and then sounds an alarm before turning itself off. The manufacturer has a new software version that reduces the probability of such an event. The company has received 14 complaints about the error messages and had shipped 4,338 of the devices between November 2007 and October 2018. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Possible Lack of Sterility in Ophthalmic Products Sold by CVS
> Issue date: July 10, 2019
> Type of alert: Recall

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products sold over-the-counter at CVS pharmacies due to an FDA determination that the products may not be sterile. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Possible Lack of Sterility in Ophthalmic Products Sold by Walgreens
> Issue date: July 3, 2019
> Type of alert: Recall

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products that may not be sterile sold over-the-counter at Walgreens pharmacies. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Possible Lack of Sterility in Ophthalmic Products Sold Under Perrigo Brand
> Issue date: July 3, 2019
> Type of alert: Recall

Altaire Pharmaceuticals is voluntarily recalling several ophthalmic products sold to Perrigo that may not be sterile, which distributes them to its own customers. According to the FDA, “Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.” The list of recalled products is available at the FDA website.

Chemotherapy Drug May Contain Glass Particulate
> Issue date: July 2, 2019
> Type of alert: Recall

Fresenius Kabi USA is voluntarily recalling two lots of its Fluorouracil intravenous chemotherapy drug used to treat a variety of cancers due to the potential for glass particulate. Using a product with glass particulate could be life-threatening.

Infusion Pump Syringe May Leak
> Issue date: July 1, 2019
> Type of alert: Recall

Becton Dickinson is recalling 2,900 SmartSite Syringe Administration sets that are used with an infusion pump to deliver fluids to patients. The sets may leak causing under‐infusion of critical medications, delay or interruption of infusions, contamination of the fluid paths and/or health care provider exposures to hazardous medications. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Device Used in Bypass Surgery May Rupture
> Issue date: July 1, 2019
> Type of alert: Recall

Edwards LifeSciences is recalling 727 IntraClude Intra-Aortic Occlusion devices due to the risk that the balloon used to block and vent the aorta during surgery may rupture causing serious adverse health consequences. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”

Also be sure to check out the medical safety alerts issued in the first half of 2019.

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