Device product
Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
Z-0546-2018
Product summary
- Event
- Event 78950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 cases
- Official record key
device-enforcement:Z-0546-2018
Official wording
Reason: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Code information: Lot Numbers/Expiration Dates: 1) 1620888/Expiration Date: 12/30/2017 2) 1620367/Expiration Date: 09/01/2017
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
foreign matter