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-1504-2009 · posted 2009-06-24 · Terminated
Recall details
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Reason for recall
- Needles separate from the barrel of the syringes.
- Action taken
- 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).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 559,500 syringes
- Distribution
- Nationwide.
- Date initiated
- 2009-04-09
- Date posted
- 2009-06-24
- Date terminated
- 2010-11-01
- Location
- Huntsville, AL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FEEL-JECT INSULIN SYRINGE (K070917) | Feel Tech | 2007-06-20 |