Recall Z-1879-2018 ยท HGI Electrocautery, Gynecologic (And Accessories)
CooperSurgical, Inc.
Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
| Date | Mar 12, 2018 |
| Status | Terminated |
| Reason | Products have been packaged with an incorrect product size. |
| Root cause | Under Investigation by firm |
| Action | On March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at recall@coopersurgical.com. |
| Quantity | 500 |
| Distribution | CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 Apple Medical Corp., Oct 20, 2006 |