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.
FDA Recall Z-1080-2016 · Posted None
Recalling FirmValue Plastics, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2015-12-18
Date Terminated2016-08-17
Product Quantity33,000
Reason for Recall
Potential for the parts to crack.
Firm 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.
Root Cause
Process control
Distribution Pattern
3 Consignees in NY, PA, MN. No foreign, VA/govt.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.