FDA Recall
Terminated
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.
Recall: Z-1080-2016
·
Initiated December 18, 2015
Recall
- Recall Number
- Z-1080-2016
- Event Number
- 72961
- Firm
- Value Plastics, Inc.
- FEI Number
- 3003182071
- Product Code
- FMG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 18, 2015
- Terminated
- August 17, 2016
- Address
- 3325 S Timberline Rd, Fort Collins, CO, 80525-2903
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
Potential for the parts to crack.
Action
Customers were initially notified by telephone call; followed by recall notice via email on 12/18/15. The recall letter instructs customers to identify their customers and notify them of the product recall. Returned product will be quarantined and separated from acceptable materials and scrapped.
Distribution
3 Consignees in NY, PA, MN. No foreign, VA/govt.
Quantity
33,000