Z-1504-2009

AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per...

Name: Z-1504-2009 AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per...
Creator: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Published: 2009-04-09
License: https://open.fda.gov/license/

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals / initiated 2009-04-09 / Terminated / root cause: manufacturing process

FDA source

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals began a recall of AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2 on 2009-04-09. The reason FDA records is "Needles separate from the barrel 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-1504-2009
Status: Terminated
Initiated: 2009-04-09
Posted: 2009-06-24
Terminated: 2010-11-01
Recalling firm: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Product: AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2
Product code: FMF Syringe, Piston
Reason for recall: Needles separate from the barrel of the syringes.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request).
Quantity in commerce: 559,500 syringes
Distribution: Nationwide.
Product codes and lots: Lot A07001, exp 07/2012

Product code FMF

K070917Class IIFeel-Ject Insulin SyringeFeel Tech / cleared 2007-06-20

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)