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U.S. Department of Health and Human Services

Class 2 Device Recall Churchill Medical Systems

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  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/
Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
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.