Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
FDA device recall Z-0005-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Liberty Medical Supplies
- Reason for recall
- The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
- Action taken
- The firm mailed a recall letter to accounts on 2/25/2003 informing the user patients of the labeling error and requesting they examine all syringes they have received from Liberty Medical for the indicated lot numbers and to call the recalling firm, Libery Medical at 800-762-8026 for replacements. Also the letter contained a mailing label for the patient to return any recalled syringes.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 630 cases of 100 syringes each.
- Distribution
- Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.
- Date initiated
- 2003-02-24
- Date posted
- 2003-10-15
- Date terminated
- 2013-07-01
- Location
- Port Saint Lucie, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUREONE INSULIN SYRINGE (K002921) | Hosuk Co., Ltd. | 2000-10-18 |