Device product
Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
Z-0544-2018
Product summary
- Event
- Event 78950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 cases
- Official record key
device-enforcement:Z-0544-2018
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) 1730650/Expiration Date: 10/30/2021; 2) 1630921/Expiration Date: 11/02/2020; 3) 1631124/Expiration Date: 10/30/2020; 4) 1631386/Expiration Date: 05/30/2021; 5) 1631679/Expiration Date: 05/30/2021
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
foreign matter