Recall Z-2158-2020 ยท NWV Laparoscopic Accessories, Gynecologic
Applied Medical Resources Corp
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
| Date | Mar 17, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 32,760 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, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.