Recall Z-0813-2014— Churchill Medical Systems, Inc.

Name: FDA recall Z-0813-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-07

Class II · Terminated

Class II FDA medical device recall by Churchill Medical Systems, Inc., initiated 2014-01-07, terminated 2014-11-03. It names one FDA 510(k) clearance: K021395. Product: AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.. Reason: Defective component may cause extension sets to leak..

Recalling firm: Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-07
Terminated: 2014-11-03
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K021395 — MODIFICATION TO 30 EXTENSION SETChurchill Medical Systems, Inc.·cleared 2002-05-13

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

AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.

Reason for recall

Defective component may cause extension sets to leak.

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