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Recall Observatory FDA recall evidence

Device product

bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

Z-0503-2018

November 03, 2017

Class II

Product summary

Firm
Beaver-Visitec International Inc.
Event
Event 78789
Status
Terminated
Classification
Class II
Quantity
123,240 units
Official record key
device-enforcement:Z-0503-2018

Official wording

Reason: The protective shield was retracted, and the blade was exposed.

Code information: Batch Numbers: 3180336 3181395 3183925 3184461 3183518 3187183 3187940 3189616 3190463 3192521 3193360 3194101 3199801 3200589 3201368 3201959 3202091 3202764 3203228 3204381 3205075 3205511 3205828 3207499 3208102 3211276 3215327 3218819 3218144 3220074 3221091 3221092 3223818 3223055 3223115 3224020 3225234

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The protective shield was retracted, and the blade was exposed.