Recall Z-2251-2013— Churchill Medical Systems, Inc.

Name: FDA recall Z-2251-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-12

Class II · Terminated

Class II FDA medical device recall by Churchill Medical Systems, Inc., initiated 2013-08-12, terminated 2014-06-16. It names one FDA 510(k) clearance: K963981. Product: Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.. Reason: Microbore tubing disconnecting from male luers on the extension sets..

Recalling firm: Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Terminated: 2014-06-16
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K963981 — VYGON BIONECTOR WITH EXTENSION SETVygon Corp.·cleared 1997-02-14

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

Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

Reason for recall

Microbore tubing disconnecting from male luers on the extension sets.

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