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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Site

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 Class 2 Device Recall Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sitesee related information
Date Initiated by FirmMarch 27, 2009
Date PostedJune 05, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall NumberZ-1433-2009
Recall Event ID 51869
510(K)NumberK790062 K955585 
Product Classification Intravascular administration set - Product Code FPA
ProductUltrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. For use with Secondary Container.
Code Information Lot #'61030997 with an expiration date of 12/31/2013 and Lot #'s 61031000, 61031001, 61031002, and 61031004 with an expiration date of 1/31/2014.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information ContactKimberly 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
ActionAn 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 Commerce52,050 units
DistributionWorldwide Distribution -- USA and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
510(K)s with Product Code = FPA
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