STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligatio

FDA device recall Z-1331-2016 · posted 2016-04-05 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.

Action taken

Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe. The customer notification letter requested that the following actions be taken: - Check inventory for recalled product. - Complete the attached Recall Notification Confirmation Form to acknowledge the recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested. - Return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60684384@appliedmedical.com or faxing to (949) 713-8936. - 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

MCH

Distribution

U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany,

Date initiated

2015-12-22

Date posted

2016-04-05

Date terminated

2016-10-03

Location

Rancho Santa Margarita, CA