Z-1080-2016 Class II Terminated
FDA device recall Z-1080-2016 was initiated by Value Plastics, Inc. on December 18, 2015 and is designated Class II. Reason for recall: Potential for the parts to crack. The recall status is terminated (terminated August 17, 2016). Affected quantity: 33,000.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2016
- Initiation Date
- December 18, 2015
- Termination Date
- August 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,000
Product Description
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.
Reason for Recall
Potential for the parts to crack.
Distribution Pattern
3 Consignees in NY, PA, MN. No foreign, VA/govt.
Code Information
Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015