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U.S. Department of Health and Human Services

Class 2 Device Recall Laparoscopic Cholecystectomy Kit

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  Class 2 Device Recall Laparoscopic Cholecystectomy Kit see related information
Date Initiated by Firm March 17, 2020
Create Date May 28, 2020
Recall Status1 Terminated 3 on February 17, 2022
Recall Number Z-2160-2020
Recall Event ID 85436
Product Classification Laparoscopic accessories, gynecologic - Product Code NWV
Product DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Code Information Batch: 1378830/Expiration Date: September 8, 2022; Batch: 1379253/Expiration Date: August 13, 2022; Batch: 1380094/Expiration Date: August 22, 2022; Batch: 1381695/Expiration Date: October 30, 2022  
Recalling Firm/
Manufacturer
Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Lauren Contursi
949-713-8000
Manufacturer Reason
for Recall
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
FDA Determined
Cause 2
Under Investigation by firm
Action Each domestic consignee was notified by Urgent: Medical Device Recall letter, dated March 16, 2020 sent to distributors 3/19/2020 via email and domestic consignees on March 19, 2020 via UPS. It notified customers of recall of specific lots due to the potential for tissue to catch on a slightly protruding riven on the distal end of the device, which may lead to tissue damage. It instructed customers to complete the following actions: 1) Check inventory for recalled product. 2) Complete the attached Customer Recall Notification Confirmation Form (Page 3) to acknowledge the Recall. Please then indicate if your facility is returning or has already used devices from this lot. Please note that you must return the form even if you have no devices in inventory. 3) If a distributor, please notify any facilities to which they distributed the affected product. Please also complete the Distributor Recall Notification Confirmation Form (Page 4). 4) Return the Customer Recall Notification Confirmation Form to Applied Medical by email at Recall60819877@appliedmedical.com or fax to (949) 688-2125. 5) Return affected product and a copy of the Customer Recall Notification Confirmation Form to Applied Medical.Product Return Instructions are on Page 5. NOTE: If a distributor, please notify any facilities to which they distributed the affected product. Also,please contact your local regulatory agency. It listed the following contact information for additional questions and/or MDR reporting: For product return questions, please contact Jaclene Rios-Simpson, RGA Dept. at (949) 713-8688 or by email atjrios@appliedmedical.com. For regulatory questions, please contact Lauren Contursi at (949) 713-8767 or by email at lcontursi@appliedmedical.com. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce 21 units
Distribution US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
Total Product Life Cycle TPLC 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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