—#81488

Product

Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Injection Site and Spin-Lock Connector, Catalog #470046. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K904518, K955585
Affected lot / code info: Lot #61046193 with an expiration date of 1/31/2012.

Why it was recalled

Device defect is occlusion/no flow.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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 immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Worldwide Distribution -- USA and Canada.

Timeline

Recall initiated: 2009-03-27
Posted by FDA: 2009-06-05
Terminated: 2009-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81488. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.