| Class 2 Device Recall Churchill Medical Systems | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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