FDA Recall
Terminated
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.
Recall: Z-2251-2013
·
Initiated August 12, 2013
Recall
- Recall Number
- Z-2251-2013
- Event Number
- 66060
- Firm
- Churchill Medical Systems, Inc.
- FEI Number
- 1000120555
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- August 12, 2013
- Posted
- September 18, 2013
- Terminated
- June 16, 2014
- Address
- 87 Venture Drive, Dover, NH, 03820-5914
Description
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.
Reason
Microbore tubing disconnecting from male luers on the extension sets.
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.
Distribution
Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
Quantity
13100