Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general sur

FDA device recall Z-1621-2016 · posted 2016-05-06 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

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

Action taken

Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60698158@appliedmedical.com or faxing to (949) 713-8921. Customers are to return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical. For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FZP

Quantity affected

559,274

Distribution

U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM,

Date initiated

2016-04-01

Date posted

2016-05-06

Date terminated

2017-02-07

Location

Rancho Santa Margarita, CA

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