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Recall Observatory FDA recall evidence

Device product

Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

Z-1879-2018

March 12, 2018

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 79828
Status
Terminated
Classification
Class II
Quantity
500
Official record key
device-enforcement:Z-1879-2018

Official wording

Reason: Products have been packaged with an incorrect product size.

Code information: Lot number: 212074

Distribution pattern: CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products have been packaged with an incorrect product size.