Device product
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
Z-0540-2018
Product summary
- Event
- Event 78950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 470 cases
- Official record key
device-enforcement:Z-0540-2018
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 Number/Expiration Date: 1) 1610300/Expiration Date 03/01/2019; 2) 1610503/Expiration Date 05/30/2019; 3) 1710059/Expiration Date: 09/30/2019; 4) 1610383/Expiration Date: 02/28/2019; 5) 1610463/Expiration Date: 05/30/2019; 6) 1610215/Expiration Date: 02/01/2019; 7) 1610114/Expiration Date: 11/01/2018; 8) 1610044/Expiration Date: 06/01/2018;
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
foreign matter