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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter NonDEHP I.V. Catheter TConnector Extension Set

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 Class 2 Recall
Baxter NonDEHP I.V. Catheter TConnector Extension Set
see related information
Date Posted October 27, 2010
Recall Status1 Terminated on September 07, 2011
Recall Number Z-0157-2011
Recall Event ID 56718
Premarket Notification
510(K) Number
K964918 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9057 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code Information product 2N9057, lots UE104968, UE105502, UE106096, UE106369, UE106971, UE107029, UE107276, UE107318, UE107664, UE107672, UE107706, UE112565, UE112953, UE113118, UE113134, UE113258, UE103440, UE103457 and UE103465
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in Commerce 104,700 sets
Distribution Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = CRITICAL DEVICE CORP.
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