Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
FDA Recall Z-0004-04 · Posted 2003-10-15
Recalling FirmLiberty Medical Supplies
Recall StatusTerminated
Product CodeFMF
Date Initiated2003-02-24
Date Terminated2013-07-01
Product Quantity4000 boxes of 100 syringes each.
Reason for Recall
The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
Firm 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.
Root Cause
Process control
Distribution Pattern
Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.