Medical Device Recall: Z-0003-04

FDA Recalls dataset · Firm: Liberty Medical Supplies · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-02-24 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-04.

Recall Res Number
Z-0003-04
Recalling Firm / Manufacturer
FEI Number
3003226337
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-02-24
Date Posted
2003-10-15
Date Terminated
2013-07-01
Product Code
FMF
Event Number
25862
Product Quantity
9,472 boxes of 100 syringes each.
Product Description Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

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 Details 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.

Distribution Pattern Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.

Code Information / Serial Numbers Lot # 2IE03

Related Establishments / Registrations

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