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U.S. Department of Health and Human Services

Class 2 Device Recall Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasie Injection Sites and SpinLock Conne

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  Class 2 Device Recall Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasie Injection Sites and SpinLock Conne see related information
Date Initiated by Firm March 27, 2009
Date Posted June 05, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-1429-2009
Recall Event ID 51869
510(K)Number K955585  K7900062  
Product Classification Intravascular administration set - Product Code FPA
Product Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and Spin-Lock Connector, Catalog # 375100.

For use with Secondary Container.
Code Information Lot #'s 61029901, 61029904, 61029906, 61029908, 61029909, 61029910, 61029911, 61029912 and 61029913 all with an expiration date of 1/31/2014.
Recalling Firm/
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
610-266-0500 Ext. 2669
Manufacturer Reason
for Recall
Device defect is occlusion/no flow.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 135,400 units
Distribution Worldwide Distribution -- USA and Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL, INC.