Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
- Recall Initiated
- March 17, 2020
- Terminated
- February 17, 2022
- Recall Number
- Z-2159-2020
- Quantity
- 4320 units
- Firm Location
- Margarita, CA
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.
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
Lot / Code Info
Batch: 1366454/ Expiration Date: August 25, 2022; Batch: 1371261/Expiration Date: October 7, 2022; Batch: 1371262/Expiration Date: October 14, 2022; Batch: 1373051/Expiration Date: October 29, 2022; Batch: 1373256/Expiration Date: December 1, 2022; Batch: 1376369/Expiration Date: December 10, 2022
Root Cause
Under Investigation by firm
Action Taken
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.