B. Braun Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0575-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Product Classification:
Class II
Date Initiated: June 21, 2017
Date Posted: February 21, 2018
Recall Number: Z-0575-2018
Event ID: 78878
Reason for Recall:
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.
Status: Terminated
Product Quantity: 460 units
Code Information:
0061522622. 0061537909.
Distribution Pattern:
US Nationwide Distribution.
Voluntary or Mandated:
Voluntary: Firm initiated