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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136

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 Class 2 Device Recall Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136see related information
Date Initiated by FirmSeptember 10, 2010
Date PostedMarch 03, 2011
Recall Status1 Terminated 3 on March 09, 2011
Recall NumberZ-1514-2011
Recall Event ID 57702
Product Classification Laparoscope, general &: plastic surgery - Product Code GCJ
ProductApplied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136 The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
Code Information LOT NUMBER(S): 1121401
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact
949-713-8000
Manufacturer 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.
FDA Determined
Cause 2		Process design
ActionApplied 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.
Quantity in Commerce2,843 units for all products
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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