• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Microbore Extension Set with Bionector

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 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-2252-2013
Recall Event ID 66060
Premarket Notification
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, 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 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 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.
-
-