Z-2247-2009

AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10...

Name: Z-2247-2009 AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10...
Creator: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Published: 2009-08-21
License: https://open.fda.gov/license/

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals / initiated 2009-08-21 / Terminated / root cause: manufacturing process

FDA source

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals began a recall of AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton on 2009-08-21. The reason FDA records is "Needles separate from the barrels of the syringes". 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-2247-2009
Status: Terminated
Initiated: 2009-08-21
Posted: 2009-09-24
Terminated: 2010-11-24
Recalling firm: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Product: AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton
Product code: FMF Syringe, Piston
Reason for recall: Needles separate from the barrels of the syringes
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall via a press release on 08/21/2009. They began notifying their consignees of the problem and the recall by letter on 08/21/2009. email: [email protected]
Quantity in commerce: 37,340 boxes of 100 units
Distribution: Nationwide
Product codes and lots: Lot 6JCB1

Product code FMF

K021197Class IISureone Insulin Syringe, 31 Gauge X 5/16Hosuk Co., Ltd. / cleared 2002-04-26

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)