Recall Z-1621-2016— Applied Medical Resources Corp

Name: FDA recall Z-1621-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-01

Class II · Terminated

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2016-04-01, terminated 2017-02-07. It names one FDA 510(k) clearance: K011236. Product: Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.. Reason: Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Terminated: 2017-02-07
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K011236 — MODIFICATION TO IMPLANTABLE CLIPApplied Medical Resources Corp.·cleared 2001-05-14

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

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

Reason for recall

Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

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