Device product
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Z-0898-2015
Product summary
- Event
- Event 69842
- Status
- Completed
- Classification
- Class II
- Quantity
- 47,200
- Official record key
device-enforcement:Z-0898-2015
Official wording
Reason: Needle is not captured in the needle safety sheath in specific lots.
Code information: Lot Numbers: 2756526, 2771498
Distribution pattern: US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
Derived failure modes
-
Unknown
Needle is not captured in the needle safety sheath in specific lots.