Recall Z-1217-2010 ยท FMF Syringe, Piston
Ulti Med, Inc.
Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock.
| Date | Mar 31, 2010 (initiated Feb 5, 2010) |
| Status | Terminated |
| Reason | UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe. |
| Root cause | Employee error |
| Action | An " IMPORTANT - DEVICE PRODUCT RECALL"letter dated February 3, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. The customers should check their inventory for the affected lot, complete the recall tracking form and return by mail or fax and contact UltiMed for return instructions. If you have any questions concerning this recall, please call UltiMed, Inc. at 877-854-3434 and ask to speak to Jill. |
| Quantity | 25 units (each dispense and dispose sharps unit contains 100 syringes) |
| Distribution | Nationwide distribution: CT and NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES Ultimed, Inc., Nov 29, 2006 |