Device 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.
Z-2251-2013
Product summary
- Event
- Event 66060
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13100
- Official record key
device-enforcement:Z-2251-2013
Official wording
Reason: Microbore tubing disconnecting from male luers on the extension sets.
Code information: 1203117, 1206030, 1212111, 1304133, 130516
Distribution pattern: Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
Derived failure modes
-
Unknown
Microbore tubing disconnecting from male luers on the extension sets.