Recall Z-1080-2016 ยท FMG Stopcock, I.V. Set
Value Plastics, Inc.
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.
| Date | Dec 18, 2015 |
| Status | Terminated |
| Reason | Potential for the parts to crack. |
| Root cause | Process control |
| 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. |
| Quantity | 33,000 |
| Distribution | 3 Consignees in NY, PA, MN. No foreign, VA/govt. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE Tronomed, Inc., Jan 16, 1980 |