Z-1080-2016Class II

Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value...

Name: Z-1080-2016 Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value...
Creator: Value Plastics, Inc.
Published: 2015-12-18
License: https://open.fda.gov/license/

Value Plastics, Inc. / initiated 2015-12-18 / Terminated / root cause: manufacturing process

FDA source

Value Plastics, Inc. began a recall of 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... on 2015-12-18. FDA classified it as Class II and gives the reason as "Potential for the parts to crack". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1080-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-03-09
Terminated: 2016-08-17
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.
Product code: FMG Stopcock, I.V. Set
Reason for recall: Potential for the parts to crack.
Root cause tag: manufacturing process
FDA 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 in commerce: 33,000
Distribution: 3 Consignees in NY, PA, MN. No foreign, VA/govt.
Product codes and lots: Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1080-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1080-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-09

Product code FMG

K792125Class II3&4 Way Plastic Stopcocks, NonsterileTronomed, Inc. / cleared 1980-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)