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FDA Medical Device Recalls (openFDA)

Liberty Medical Supplies: Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

Recall number
Z-0004-04
Recalling firm
Liberty Medical Supplies
Product
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Status
Terminated
Initiated
2003-02-24
Posted
2003-10-15
Terminated
2013-07-01
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
4000 boxes of 100 syringes each.
Distribution
Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.
Lot, serial or model codes
Lot # 2HC02
510(k) numbers
["K002921"]
PMA numbers
not on file
Product code
FMF
Firm FEI
3003226337
Firm city
Port Saint Lucie
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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