Recall Z-1539-2009 ยท FPA Set, Administration, Intravascular
C.R. Bard, Inc., Urological Division
Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
| Date | Jun 29, 2009 (initiated Apr 2, 2009) |
| Status | Terminated |
| Reason | The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing. |
| Root cause | Process control |
| Action | All consignees were notified by an Urgent: Product Recall Notification letter via Fed-Ex carrier on 04/02/2009. They were instructed not to use or further distribute any of the affected products. They were advised to check their inventory and to remove and return affected product to Bard Medical Division. A Recall & Effectiveness Check Form was included to be filled out and returned via fax, to Bard. |
| Quantity | 16,100 units |
| Distribution | Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980992 | IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES Venetec Intl., Inc., May 28, 1998 |