Date Initiated by Firm | August 12, 2013 |
Date Posted | September 18, 2013 |
Recall Status1 |
Terminated 3 on June 16, 2014 |
Recall Number | Z-2251-2013 |
Recall Event ID |
66060 |
510(K)Number | K963981 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. |
Code Information |
1203117, 1206030, 1212111, 1304133, 130516 |
Recalling Firm/ Manufacturer |
Churchill Medical Systems, Inc. 87 Venture Drive Dover NH 03820-5914
|
For Additional Information Contact | 800-473-5414 |
Manufacturer Reason for Recall | Microbore tubing disconnecting from male luers on the extension sets. |
FDA Determined Cause 2 | Under Investigation by 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 | 13100 |
Distribution | Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA. |
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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