Recall Z-0898-2015 ยท FMI Needle, Hypodermic, Single Lumen
Smiths Medical ASD, Inc.
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.
| Date | Dec 30, 2014 (initiated Nov 21, 2014) |
| Status | Completed |
| Reason | Needle is not captured in the needle safety sheath in specific lots. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 47,200 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041399 | HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE Smiths Medical Asd, Inc., Jul 28, 2004 |