FDA Device

IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container.

Hazard

Device defect is occlusion/no flow.

What You Should Do

Remedy

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.

Products

IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container.
Brand
B. Braun Medical, Inc.
UPC
Catalog #352049 - Lot #'s 61028761, 61028762, 61028763, 61028764, 61028765, 61028766, 61028767, 61028769, 61028771, and 61028772 all with an expiration date of 1/31/2014.

Units Affected

178,051 units