Beaver Visitec International, Inc.: Device Recall

Recall Details

Recall Number

Z-2161-2024

Classification

Class II

Product Type

Device

Recalling Firm

Beaver Visitec International, Inc.

Status

Ongoing

Date Initiated

05/10/2024

Location

Waltham, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1300 units

Reason for Recall

The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).

Product Description

Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.

Other Recalls by Beaver Visitec International, Inc.

• Class II: Risk 12/05/2025
  Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
• Class II: Risk 07/26/2024
  Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.

View all recalls by Beaver Visitec International, Inc. →