Z-0942-05

AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10...

Name: Z-0942-05 AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10...
Creator: Qualitest Pharmaceuticals Inc
Published: 2005-06-14
License: https://open.fda.gov/license/

Qualitest Pharmaceuticals Inc / initiated 2005-06-14 / Terminated / root cause: labeling and UDI

FDA source

Qualitest Pharmaceuticals Inc began a recall of AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21 on 2005-06-14. The reason FDA records is "Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0942-05
Status: Terminated
Initiated: 2005-06-14
Posted: 2005-06-30
Terminated: 2006-05-10
Recalling firm: Qualitest Pharmaceuticals Inc
Product: AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.
Product code: FMF Syringe, Piston
Reason for recall: Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm initiated the recall on June 14, 2005 with a press release and followed with a letter initially sent via fax and then by letter requesting return of the product and posting of a copy of the press release at the retail level.
Quantity in commerce: unknown
Distribution: Nationwide
Product codes and lots: All codes

Product code FMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)