Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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

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


New Search Back to Search Results
  Class 2 Device Recall Churchill Medical Systems see related information
Date Initiated by Firm October 20, 2009
Date Posted May 21, 2010
Recall Status1 Terminated 3 on March 28, 2013
Recall Number Z-1639-2010
Recall Event ID 54174
510(K)Number K011336  
Product Classification Set, administration, intravascular - Product Code FPA
Product Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820.

Intravascular administration set.
Code Information Lot Numbers: 903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091, 906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018, 909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037.
Recalling Firm/
Manufacturer		 Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
603-743-5988
Manufacturer Reason
for Recall		 Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents
FDA Determined
Cause 2		 Process change control
Action Churchill Medical Systems issued an "Urgent: Product Advisory Customer Notification" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328.
Quantity in Commerce 283,900 each
Distribution Distributed to Florida.
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 = CHURCHILL MEDICAL SYSTEMS, INC.
-
-