Recall Z-0444-2016 ยท FMI Needle, Hypodermic, Single Lumen
Myco Medical Supplies Inc
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
| Date | Dec 17, 2015 (initiated Nov 6, 2015) |
| Status | Terminated |
| Reason | Particulates: Complaints of rubber coring from the closure of injection vials. |
| Root cause | Under Investigation by firm |
| Action | MYCO Medical sent an Advisory Notice dated November 6, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, if any affected product found MYCO request that the customer return the product to MYCO Medical following the instructions provided on the Materials for Return Form. Customers with questions were instructed to call Customers Service at 919-460-2535/ customerservice&mycomedical.com or cal the Quality Department at 919-460-2535/ QA@mycomedical.com. |
| Quantity | 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs) |
| Distribution | Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945225 | DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES Myco Medical Supplies, Inc., Jan 26, 1995 |