FDA Device recall Z-2160-2020
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 by Applied Medical Resources, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2160-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-17 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Applied Medical Resources |
| Distribution | 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 |
Product
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
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.
Identifiers
| code_info | Batch: 1378830/Expiration Date: September 8, 2022; Batch: 1379253/Expiration Date: August 13, 2022; Batch: 1380094/…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2160-2020%22
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