AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 p
FDA device recall Z-0576-2010 · posted 2009-12-28 · Terminated
Recall details
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Reason for recall
- Needles are becoming dislodged from the barrels.
- Action taken
- The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 97,045 cartons of 100
- Distribution
- Nationwide
- Date initiated
- 2009-10-27
- Date posted
- 2009-12-28
- 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 |
|---|---|---|
| FEEL-FINE INSULIN PEN NEEDLE (K080904) | Feel Tech | 2008-06-04 |
| SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 (K021197) | Hosuk Co., Ltd. | 2002-04-26 |