Recall Z-0643-2014 ยท MEG Syringe, Antistick
Smiths Medical ASD, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
| Date | Jan 8, 2014 (initiated Jul 10, 2013) |
| Status | Terminated |
| Reason | Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes |
| Root cause | Storage |
| Action | The firm, Smiths Medical, sent an "URGENT FIELD SAFETY NOTICE" dated July 10, 2013 to its consignees/customers and distributors. The notice described the product, problem and actions to be taken. The Distributors were instructed to notify their customers. The consignees/customers were instructed to inspect your inventory for the suspect lots and remove all affected devices from use and complete and return the Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to FNS@smiths-medical.com within five (5) days of receipt of this notice. If you or your facility has |
| Quantity | 93700 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063755 | PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE Smiths Medical Asd, Inc., Feb 27, 2007 |