Home / Recalls / Medical Devices
B. Braun Medical, Inc. recalls Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional
Recalled February 21, 2018 · FDA recall Z-0575-2018 · B. Braun Medical
Hazard
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process. · FDA Class II
Units
460 units
Sold at
US Nationwide Distribution.
Description
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
Product
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Manufacturer(s)
B. Braun Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →