Recalls / —
—#131691
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.
- 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 Number: 2755713
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 #131691. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.