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: Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology Models Numbers: Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX,…
Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set
DATE NOTIFICATION INITIATED: August 18, 2021 PRODUCT / LOT NUMBER: Level 1® Fluid WarmerModel Numbers: H-1000, H-500 Level 1® Fluid Warming SystemModel Numbers: H-1028, H-1200 NORMOFLO® Fluid WarmerModel Number: H-1025 Level 1® Normothermic I.V. Fluid Administration SetModel Numbers: D-100, D-300, D-50, D-60HL, D-70, DI-100, DI-300, DI-50, DI-60HL, DI-70 MANUFACTURER: Smiths Medical ASD Inc.Minneapolis, MN REASON:…
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits – Letter to Clinical Laboratory Staff and Health Care Providers
September 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false positive results with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. The false positive results may be related to current mixing…
Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-nitroso-varenicline above acceptable daily intake level Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Varenicline tablets Company Announcement Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1…
Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets 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: NORMOFLO Irrigation Fluid Warmer and NORMOFLO Irrigation Warming Set Product Codes: See recall database Model Numbers: See full list of affected medical devices Manufacturing Dates:…
Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices – Letter to Health Care Providers
September 15, 2021 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the use of certain fluid warmers and the potential for aluminum leaching and exposing the patient to high levels of aluminum. Based on information reviewed by the FDA, aluminum leaching may occur when the fluid warmer is designed with…
Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination
Summary Company Announcement Date: September 13, 2021 FDA Publish Date: September 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Exceeds Specification for Total Yeast and Mold Counts Company Name: Jacobus Pharmaceutical Company Inc. Brand Name: Brand Name(s) Product Description: Product Description Ruzurgi® (amifampridine) 10 mg tablets Company Announcement Plainsboro, New Jersey, Jacobus…
All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
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: ultrasound gel products and lotions manufactured by Eco-Med are marketed by a number of distributors, under different product names, which include but are not limited…
ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter
Summary Company Announcement Date: September 03, 2021 FDA Publish Date: September 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of visible particulate matter Company Name: ICU Medical, Inc. Brand Name: Brand Name(s) Product Description: Product Description Aminosyn II, 15%, An Amino Acid Injection, Sulfite Company Announcement ICU Medical, Inc. is voluntarily…
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
Summary Company Announcement Date: September 08, 2021 FDA Publish Date: September 08, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product kit may contain incorrect diluent. Company Name: Azurity Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Company Announcement Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of…