Device product
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
Z-1577-2013
Product summary
- Event
- Event 65243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,326,000 units
- Official record key
device-enforcement:Z-1577-2013
Official wording
Reason: There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
Code information: Catalog/Lot Number: REF#305950 Lot 2132028 and Lot 2159189
Distribution pattern: Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.
Derived failure modes
-
Unknown
There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.