Recall Z-0199-2009 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.
| Date | Oct 24, 2008 (initiated Sep 17, 2008) |
| Status | Terminated |
| Reason | Product was assembled incorrectly and connected to the wrong part. |
| Root cause | Employee error |
| Action | The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the "Product Removal Acknowledgement" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and r |
| Quantity | 3900 units |
| Distribution | Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955585 | V2 INJECTION SITE B.Braun Medical, Inc., May 15, 1996 |