Recall Z-1428-2009 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.
| Date | Jun 5, 2009 (initiated Mar 27, 2009) |
| Status | Terminated |
| Reason | Device defect is occlusion/no flow. |
| Root cause | Mixed-up of materials/components |
| Action | An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediate |
| Quantity | 13,008 units |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |