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U.S. Department of Health and Human Services

Class 2 Device Recall Microbore Extension Set with Bionector

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 Class 2 Recall
Microbore Extension Set with Bionector
see related information
Date Posted September 18, 2013
Recall Status1 Terminated on June 16, 2014
Recall Number Z-2251-2013
Recall Event ID 66060
Premarket Notification
510(K) Number
K963981 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Code Information 1203117, 1206030, 1212111, 1304133, 130516
Recalling Firm/
Manufacturer
Churchill Medical Systems, Inc.
87 Venture Drive
Dover, New Hampshire 03820-5914
Manufacturer Reason
for Recall
Microbore tubing disconnecting from male luers on the extension sets.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action "Urgent Medical Device Recall" letters were sent to each customer via courier service on August 12, 2013. Consignees were provided with a description of the issue and instructions on how to handle product that they received and that was further distributed by them. Questions were directed to customer service at 1-800-473-5414.
Quantity in Commerce 13100
Distribution Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
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 = VYGON CORP.
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