FDA Medical Device Recalls (openFDA)
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: 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
- Recall number
- Z-1504-2009
- 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
- Status
- Terminated
- Initiated
- 2009-04-09
- Posted
- 2009-06-24
- Terminated
- 2010-11-01
- Reason
- Needles separate from the barrel of the syringes.
- 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
- 559,500 syringes
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot A07001, exp 07/2012
- 510(k) numbers
- ["K070917"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3003197096
- Firm city
- Huntsville
- Firm state
- AL
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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