FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1080-2016
- Recalling firm
- Value Plastics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-12-18
- Posted
- not on file
- Terminated
- 2016-08-17
- 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.
- Lot, serial or model codes
- Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015
- 510(k) numbers
- ["K792125"]
- PMA numbers
- not on file
- Product code
- FMG
- Firm FEI
- 3003182071
- Firm city
- Fort Collins
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28