Recall Z-1226-2007 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.
| Date | Sep 20, 2007 (initiated Jun 21, 2007) |
| Status | Terminated |
| Reason | Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product. |
| Root cause | Other |
| Action | 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. |
| Quantity | 644,500 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024112 | BD INSULIN SYRINGE Becton, Dickinson & CO, Jan 9, 2003 |