Recall Z-0003-04 ยท FMF Syringe, Piston
Liberty Medical Supplies
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
| Date | Oct 15, 2003 (initiated Feb 24, 2003) |
| Status | Terminated |
| Reason | The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box . |
| Root cause | Process control |
| Action | 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. |
| Quantity | 9,472 boxes of 100 syringes each. |
| Distribution | Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002921 | SUREONE INSULIN SYRINGE Hosuk Co., Ltd., Oct 18, 2000 |