Custom Assembly — Class II medical device recall Z-1080-2016
Terminated recall by Value Plastics, Inc., reported 2016-03-16, distributed in MN, NY, PA. Potential for the parts to crack.
| Recall number | Z-1080-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Value Plastics, Inc., Fort Collins, CO, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-03-09 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-08-17 |
| Distributed | MN, NY, PA |
| Quantity | 33,000 |
| Reason classes | packaging |
| Lot numbers | 152127, 152903, 153015, 67775, 69321, 69814, 70178, 71812 |
| Model numbers | FCA026-001 |
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.
Reason for recall
Potential for the parts to crack.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1080-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.