Device product
Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
Z-0543-2018
Product summary
- Event
- Event 78950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cases
- Official record key
device-enforcement:Z-0543-2018
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) 1720047/Expiration Date: 02/20/2018
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
foreign matter