Recall Z-2251-2013 ยท FPA Set, Administration, Intravascular
Churchill Medical Systems, Inc.
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.
| Date | Sep 18, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | Microbore tubing disconnecting from male luers on the extension sets. |
| Root cause | 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 | 13100 |
| Distribution | Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963981 | VYGON BIONECTOR WITH EXTENSION SET Vygon Corp., Feb 14, 1997 |