Summary Company Announcement Date: October 18, 2021 FDA Publish Date: October 19, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Complaints of rust on the products Company Name: Cook Medical Brand Name: Brand Name(s) Cook Medical Product Description: Product Description Transseptal Needle and Transseptal Needle Catheter Company Announcement Bloomington, Ind. — On…
Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication
Date Issued: October 12, 2021 The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. The FDA is aware of the potential for overdose if the user does not clear the moat area…
Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results
The recall described in this notice is due to the same issue that was announced in the September 17, 2021 Letter to Health Care Providers: Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits. The FDA has identified this as a Class I recall, the most…
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity
Summary Company Announcement Date: October 14, 2021 FDA Publish Date: October 14, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description API batches above the specification limit for the impurity, N-nitrosoirbesartan Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg…
UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers
October 13, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these…
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency
Summary Company Announcement Date: October 12, 2021 FDA Publish Date: October 12, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super Potent Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Teligent Pharma, Inc. Product Description: Product Description Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Company Announcement Buena, NJ, Teligent Pharma, Inc….
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
Date Issued: October 5, 2021 The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test…
Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication
Date Issued: October 8, 2021 The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers. The FDA is aware…
DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Product Codes for CYSTO Pack PGYBK/89-5721.03 and GU TUR BASIN SET PGYBK/89-6425.07: See Recall Database…
UPDATE: Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers
October 7, 2021 The U.S. Food and Drug Administration (FDA) is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal use. In addition, we are announcing new actions we are taking to help ensure the safe use…