Z-0003-04

Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

Name: Z-0003-04 Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Creator: Liberty Medical Supplies
Published: 2003-02-24
License: https://open.fda.gov/license/

Liberty Medical Supplies / initiated 2003-02-24 / Terminated / root cause: manufacturing process

FDA source

Liberty Medical Supplies began a recall of Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes on 2003-02-24. The reason FDA records is "The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0003-04
Status: Terminated
Initiated: 2003-02-24
Posted: 2003-10-15
Terminated: 2013-07-01
Recalling firm: Liberty Medical Supplies
Product: Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Product code: FMF Syringe, Piston
Reason for recall: The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
Root cause tag: manufacturing process
FDA 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 in commerce: 9,472 boxes of 100 syringes each.
Distribution: Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.
Product codes and lots: Lot # 2IE03

Product code FMF

K002921Class IISureone Insulin SyringeHosuk Co., Ltd. / cleared 2000-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)