Device product
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
Z-1937-2016
Product summary
- Event
- Event 73828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 811,200 units
- Official record key
device-enforcement:Z-1937-2016
Official wording
Reason: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Code information: Catalog (REF #) 309642, Lot #'s 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729 and 5017735
Distribution pattern: Nationwide Distribution to NY only
Derived failure modes
-
Unknown
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.