Z-1088-2019 Class III Terminated

Recalled by Beaver Visitec — Waltham, MA

FDA device recall Z-1088-2019 was initiated by Beaver Visitec on February 19, 2019 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated July 21, 2020). Affected quantity: 97 boxes (10units/box).

Recall Details

Product Type
Devices
Report Date
April 10, 2019
Initiation Date
February 19, 2019
Termination Date
July 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
97 boxes (10units/box)

Product Description

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. .

Reason for Recall

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.

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.

Code Information

Lot Number 180615