Device product
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
Z-1080-2016
Product summary
- Event
- Event 72961
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,000
- Official record key
device-enforcement:Z-1080-2016
Official wording
Reason: Potential for the parts to crack.
Code information: Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015
Distribution pattern: 3 Consignees in NY, PA, MN. No foreign, VA/govt.
Derived failure modes
-
Unknown
Potential for the parts to crack.