| Class 2 Device Recall Applied Medical's LAP CHOLE KIT BLADED; Model Number: K0552 | |
Date Initiated by Firm | September 10, 2010 |
Date Posted | March 03, 2011 |
Recall Status1 |
Terminated 3 on March 09, 2011 |
Recall Number | Z-1510-2011 |
Recall Event ID |
57702 |
Product Classification |
Laparoscope, general &: plastic surgery - Product Code GCJ
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Product | Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552
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): 1121587 |
Recalling Firm/ Manufacturer |
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa Margarita CA 92688-2650
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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 |
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. |
Quantity in Commerce | 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, Europe, Japan, and Kuwait. |
Total Product Life Cycle | TPLC Device Report |
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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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