Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used t
FDA device recall Z-1217-2010 · posted 2010-03-31 · Terminated
Recall details
- Recalling firm
- Ulti Med, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 25 units (each dispense and dispose sharps unit contains 100 syringes)
- Distribution
- Nationwide distribution: CT and NJ
- Date initiated
- 2010-02-05
- Date posted
- 2010-03-31
- Date terminated
- 2011-05-07
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTICARE DISPOSABLE SYRINGES AND NEEDLES (K062702) | Ultimed, Inc. | 2006-11-29 |