Device product
Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
Z-0545-2018
Product summary
- Event
- Event 78950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1037 in total
- Official record key
device-enforcement:Z-0545-2018
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) 1710206/Expiration Date: 05/30/2022; 2) 1710040/Expiration Date: 01/30/2022; 3) 1610536/Expiration Date: 12/30/2021; 4) 1610423/No Expiration Date; 5) 1610351/No Expiration Date; 6) 1610219/No Expiration Date; 7) 1610090/No Expiration Date
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
foreign matter