Recall Z-1840-2019 ยท HGI Electrocautery, Gynecologic (And Accessories)
CooperSurgical, Inc.
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical curre
| Date | Apr 23, 2019 |
| Status | Terminated |
| Reason | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses. |
| Root cause | Process control |
| Action | On April 23, 2019, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to immediately discontinue use of the discrepant product, quarantine the product, and replace the 2 main fuses with the 2 fuses provided with the firm's mailing. Customers were provided with instructions to replace the fuses. Once customers have successfully completed the fuse replacement, they are asked to complete the Acknowledgement and Receipt form and return it to CooperSurgical. If y |
| Quantity | 19 |
| Distribution | US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963348 | WALLACH INTEGRATION UNIT Wallach Surgical Devices, Inc., Mar 19, 1997 |