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

Class 2 Device Recall Churchill Medical Systems 6" Microbore Trifurcated

  • 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
Churchill Medical Systems 6" Microbore Trifurcated
see related information
Date Posted February 16, 2011
Recall Status1 Terminated on May 01, 2012
Recall Number Z-1326-2011
Recall Event ID 57295
Premarket Notification
510(K) Number
K021395 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter Item Number: AMS-944 Intended use: Intravascular Administration Set
Code Information Lot Number: 1009163
Recalling Firm/
Manufacturer
Churchill Medical Systems, Inc.
87 Venture Drive
Dover, New Hampshire 03820-5914
Manufacturer Reason
for Recall
Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control
Action The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.
Quantity in Commerce 1,000 units
Distribution Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, 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 = CHURCHILL MEDICAL SYSTEMS, INC.
-
-