FDA Medical Device Recalls (openFDA)
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals: AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton
- Recall number
- Z-2248-2009
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Product
- AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton
- Status
- Terminated
- Initiated
- 2009-08-21
- Posted
- 2009-09-24
- Terminated
- 2010-11-24
- Reason
- Needles separate from the barrels of the syringes
- 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: recallresponse@qualitestrx.com
- Quantity
- 16,520 boxes of 100 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot 7CPT1
- 510(k) numbers
- ["K021197"]
- 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
- 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
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