Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
FDA Recall Z-1511-2011 · Posted 2011-03-03
Recalling FirmApplied Medical Resources Corp
Recall StatusTerminated
Product CodeGCJ
Date Initiated2010-09-10
Date Terminated2011-03-09
Product Quantity2,843 units for all products
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.
Firm Action
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
Distribution Pattern
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, Europe, Japan, and Kuwait.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.