AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per p
FDA device recall Z-2247-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Reason for recall
- Needles separate from the barrels of the syringes
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 37,340 boxes of 100 units
- Distribution
- Nationwide
- Date initiated
- 2009-08-21
- Date posted
- 2009-09-24
- Date terminated
- 2010-11-24
- Location
- Huntsville, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 (K021197) | Hosuk Co., Ltd. | 2002-04-26 |