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B. Braun Medical, Inc. recalls Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin p
Recalled February 21, 2018 · FDA recall Z-0567-2018 · 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 tothe 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
8630 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 tothe 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
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. 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 →