Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
FDA Recall Z-1879-2018 · Posted None
Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHGI
Date Initiated2018-03-12
Date Terminated2019-05-08
Product Quantity500
Reason for Recall
Products have been packaged with an incorrect product size.
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.