Customer Epidural Anesthesia Tray recalled over foreign material

Recall date

June 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

B. Braun Medical, Inc. recalls Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of t…

Recall number

Z-0574-2018

FDA classification

Class II

Brand / firm

B. Braun Medical, Inc.

Sold / distributed

US Nationwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.