ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.
FDA device recall Z-1226-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
- Action taken
- Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 644,500 units
- Distribution
- Nationwide.
- Date initiated
- 2007-06-21
- Date posted
- 2007-09-20
- Date terminated
- 2008-06-03
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD INSULIN SYRINGE (K024112) | Becton, Dickinson & CO | 2003-01-09 |