| Class 2 Device Recall IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin | |
Date Initiated by Firm | March 27, 2009 |
Date Posted | June 05, 2009 |
Recall Status1 |
Terminated 3 on December 15, 2009 |
Recall Number | Z-1427-2009 |
Recall Event ID |
51869 |
510(K)Number | K955585 |
Product Classification |
Intravascular administration set - Product Code FPA
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Product | IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049.
For use with Secondary Container. |
Code Information |
Catalog #352049 - Lot #'s 61028761, 61028762, 61028763, 61028764, 61028765, 61028766, 61028767, 61028769, 61028771, and 61028772 all with an expiration date of 1/31/2014. |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Boulevard Allentown PA 18109-9512
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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 | 178,051 units |
Distribution | Worldwide Distribution -- USA and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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