Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip in order to ligate a tubular st

FDA device recall Z-1511-2011 · posted 2011-03-03 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Applied Medical is conducting a voluntary recall of specific lot numbers of the Direct Drive Laparoscopic Clip Applier, model number CA090, due to a potential defect in the jaws, possibly resulting in jaw breakage.

Action taken

Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.

Root cause

Process design

Status

Terminated

Product code

GCJ

Quantity affected

2,843 units for all products

Distribution

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia

Date initiated

2010-09-10

Date posted

2011-03-03

Date terminated

2011-03-09

Location

Rancho Santa Margarita, CA