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Recall Observatory FDA recall evidence

Device product

Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .

Z-1088-2019

February 19, 2019

Class III

Product summary

Firm
Beaver Visitec
Event
Event 82248
Status
Terminated
Classification
Class III
Quantity
97 boxes (10units/box)
Official record key
device-enforcement:Z-1088-2019

Official wording

Reason: The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.

Code information: Lot Number 180615

Distribution pattern: US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.