Search Results for: catheter

Summary Company Announcement Date: August 07, 2020 FDA Publish Date: August 10, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential fungal contamination - Aspergillus penicillioides Company Name: (Becton, Dickinson and Company) Brand Name: Brand Name(s) (Becton, Dickinson and Company) Product … [Read more...]

Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 26, 2019 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential leakage at joint between blood filter and tubing Company Name: B. Braun Medical, Inc. Brand Name: Brand Name(s) Product Description: Product … [Read more...]

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two … [Read more...]

SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.   Administration of a drug product that may contain … [Read more...]

Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code. AFFECTED PRODUCT PART NUMBER CS100i IABP 0998-UC-0446HXX; 0998-UC-0479HXX CS100 IABP 0998-00-3013-XX; 0998-UC-3013-XX CS300 IABP 0998-00-3023-XX; … [Read more...]