—#131688

Product

Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 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.

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041399
Affected lot / code info: Lot Numbers: 2731779, 2763138, 2771516, 2771517

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

Smith Medical sent on 11/24/2014, consignees an Urgent Field Safety Notice via FedEx Overnight. The notification instructs customers to inspect their inventory and complete and return the attached Urgent Field Safety Notice Confirmation Form to coordinate return of affected product to Smiths Medical for replacement/credit. For questions regarding this information, please contact Smiths Medicals Customer Service Department at 800-258-5361.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

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

Timeline

Recall initiated: 2014-11-21
Posted by FDA: 2014-12-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131688. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.