Recall Z-1080-2016— Value Plastics, Inc.

Name: FDA recall Z-1080-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Class II · Terminated

Class II FDA medical device recall by Value Plastics, Inc., initiated 2015-12-18, terminated 2016-08-17. It names one FDA 510(k) clearance: K792125. 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: Potential for the parts to crack..

Recalling firm: Value Plastics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Terminated: 2016-08-17
Firm location: Fort Collins, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K792125 — 3&4 WAY PLASTIC STOPCOCKS, NONSTERILETronomed, Inc.·cleared 1980-01-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.