Recall Z-2407-2008 ยท FRN Pump, Infusion
B. Braun Medical, Inc.
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
| Date | Sep 23, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | incorrect burette was packaged with the product |
| Root cause | Mixed-up of materials/components |
| Action | The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance. |
| Quantity | 13,360 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |