Device product
Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
Z-0542-2018
Product summary
- Event
- Event 78950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82 cases
- Official record key
device-enforcement:Z-0542-2018
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) 1610197/Expiration Date: 12/01/2018; 2) 1610204/Expiration Date: 02/01/2019; 3) 1610075/Expiration Date: 06/01/2018; 4) 1610431/Expiration Date: 05/30/2019; 5) 1610246/Expiration Date: 02/01/2019; 6) 1610204/Expiration Date: 02/01/2019
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
foreign matter