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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 Device Recall Microbore Extension Set with Bionector see related information
Date Initiated by Firm August 12, 2013
Date Posted September 18, 2013
Recall Status1 Terminated 3 on June 16, 2014
Recall Number Z-2252-2013
Recall Event ID 66060
510(K)Number K963981  
Product Classification Set, administration, intravascular - Product Code FPA
Product Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"
Code Information Lot Numbers: 1303022, 1304065
Recalling Firm/
Manufacturer		 Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
800-473-5414
Manufacturer Reason
for Recall		 Microbore tubing disconnecting from male luers on the extension sets.
FDA Determined
Cause 2		 Under Investigation by 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 3040
Distribution Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
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 = VYGON CORP.
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