FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 22, 2021 - 18:55 GMT

Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers

December 22, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about our ongoing evaluation and monitoring of device failures associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 17, 2021 - 21:41 GMT

Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine - Letter to Clinical ...

December 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false reactivity, or "false-positive", Rapid Plasma Reagin (RPR; non-treponemal) test results, when using the Bio- …

Distribution channels:

Published on December 16, 2021 - 14:28 GMT

Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid ...

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: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 30, 2021 - 05:00 GMT

Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

Summary Company Announcement Date: November 26, 2021 FDA Publish Date: November 30, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Inner lumen may detach from the device’s basket Company Name: Teleflex Incorporated …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 24, 2021 - 01:10 GMT

P&G Issues Voluntary Recall of Specific Old Spice and Secret Aerosol Spray Antiperspirants and Old Spice Below Deck Aerosol Spray ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels:

Published on November 22, 2021 - 17:39 GMT

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2021 - 20:44 GMT

American Screening LLC issues a Voluntary Nationwide Recall of American Screening Hand Sanitizer Packaged in 8 oz Bottles Because ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels:

Published on November 18, 2021 - 05:01 GMT

Odor-Eaters® Issues Voluntary Nationwide Recall of Specific Lots of Odor- Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 17, 2021 - 21:05 GMT

Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care ...

November 17, 2021 The U.S. Food and Drug Administration (FDA) is reminding providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. Cardiac perforation is a rare complication of any pacemaker …

Distribution channels:

Published on November 16, 2021 - 01:13 GMT

SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels:

Published on November 12, 2021 - 20:19 GMT

Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety ...

Date Issued: 11/12/2021 The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 29, 2021 - 18:53 GMT

Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure

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 Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Product Codes and Lot Numbers: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 29, 2021 - 18:00 GMT

Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software

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 ROSA One 3.1 Brain Application Product Codes and Lot Numbers: See Recall Database Entry Devices …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 27, 2021 - 22:34 GMT

Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels:

Published on October 27, 2021 - 17:40 GMT

artnaturals® Issues Voluntary Recall of Limited Batches of 8oz Bottles of Scent Free Hand Sanitizer Due to Presence of Impurities

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels:

Published on October 20, 2021 - 21:00 GMT

Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate ...

Summary Company Announcement Date: October 19, 2021 FDA Publish Date: October 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains particulate matter identified as glass Company Name: Merck Brand Name: Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 19, 2021 - 19:54 GMT

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 19, 2021 - 17:29 GMT

Cook Medical Issues Voluntary Recall of Transseptal Needle and Transseptal Needle with Catheter

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels:

Published on October 14, 2021 - 18:33 GMT

Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-...

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 14, 2021 - 16:03 GMT

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide ...

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: …

Distribution channels: Healthcare & Pharmaceuticals Industry