Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Catheter balloon may not deflate as intended Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Coronary dilatation catheters Company Announcement Abbott has voluntarily recalled specific lots of two catheters…

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 21, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible underdosing or overdosing Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals U.S.A., Inc. Product Description: Product Description Phenytoin Oral Suspension USP, 125 mg/5 mL Company Announcement Taro Pharmaceuticals…

Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate

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: NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation CathetersModels: Balloon diameters 4.0mm, 4.5mm and 5.0mmLots: See a full list of affected devices Distribution…

Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication – FDA Requests Withdrawal of Weight-Loss Drug

[Posted 02/13/2020] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.  When FDA approved lorcaserin…

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

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 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) – all lots before October 2019 Model 670G (MMT-1780) – all lots before August 2019 Distribution Dates: Model 630G…

GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation

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 GE Carestation 600 series anesthesia systems Model numbers 620/650/650c, A1 Serial numbers: 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002 Manufacturing Dates: August 2018 to July 2019 Distribution Dates:…

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values

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 Airway Gas Option N-CAiO (00840682104074) and CARESCAPE Respiratory Modules E-sCO (00840682104173), sCOVX (00840682104289, E-sCAiO (00840682104180), E-sCAiOV (00840682104142), E-sCAiOE (00840682104135), E-sCAiOVE (00840682104302) Serial numbers: Manufacturing Dates: June 7,…

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

Summary Company Announcement Date: January 31, 2020 FDA Publish Date: January 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description due to Microbial Contamination Company Name: Efficient Laboratories, Inc. Brand Name: Brand Name(s) Product Description: Product Description Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid Company Announcement Efficient Laboratories, Inc….