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FDA (Device enforcement)Recalled 2021-10-08class ii

Beaver Visitec International, Inc.: bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a compone

Is my product affected?

bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

  • UPC 00886158112839
  • UPC 30886158112830
  • UPC 50886158112834

Check against the official notice below — it lists the full affected range.

What happened

Beaver Visitec International, Inc. is recalling Beaver Xstar Crescent Knife surgical blades (2.5mm, 55 degrees) that were packaged as bevel-down but actually contain bevel-up blades. The affected product is a component of the bvi CustomEyes Kit-AMO Germany GmbH Cataract-set and Dr. Wagner CustomEyes Cataract Surgical Kits. The recall involves 500 units distributed nationwide and internationally to Australia, Austria, France, Germany, the Netherlands, Spain, Japan, Russia, South Africa, and the UK. The affected lot numbers are 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, and 6033588.

The record does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

Details from the source

Reason for recall: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades Distribution: Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK Quantity: 500 eaches Lot/code info: Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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