Skip to content
Recall Observatory FDA recall evidence

Device product

Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 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-0899-2015

November 21, 2014

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 69842
Status
Completed
Classification
Class II
Quantity
10,000
Official record key
device-enforcement:Z-0899-2015

Official wording

Reason: Needle is not captured in the needle safety sheath in specific lots.

Code information: Lot Number: 2755713

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

    reason.no_named_rule · v1.0.0

    Needle is not captured in the needle safety sheath in specific lots.