Z-0575-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- June 21, 2017
- Termination Date
- April 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 460 units
Product Description
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
0061522622. 0061537909.