Beaver Visitec International, Inc.: Xstar Safety Slit Knife Recalled Due to Incorrect Blade Configuration

Agency Publication Date: June 20, 2024

Summary

Beaver Visitec International, Inc. has recalled approximately 1,426 units of the Xstar Safety Slit Knife and CustomEye Kits because the surgical blade was packaged in the wrong configuration. The blade's bevel (the slanted edge) was manufactured on the back side (bevel down) instead of the front side (bevel up) as intended. This defect affects model number 378227 and specific CustomEye Kits sold in the United States and internationally. Consumers should contact their healthcare provider or the manufacturer to address any concerns regarding these devices.

Risk

The incorrect orientation of the blade bevel can lead to surgical complications or unintended tissue damage during medical procedures if the surgeon is unaware the blade is facing the wrong direction.

What You Should Do

Identify if you have the affected products by checking for Xstar Safety Slit Knife (Model 378227) with UDI-DI 00886158001652 and Lot Number 6058854.
Check your inventory for CustomEye Kits with numbers 584562 (lots 6068524, 6068025) or 5800109 (lot 6068285).
If you possess an affected knife or kit, immediately stop using the product and set it aside to prevent use in surgical procedures.
Contact Beaver Visitec International, Inc. at their Waltham, Massachusetts location or through their official website to receive instructions on returning the defective products or obtaining replacements.
If you have already undergone a procedure where this device was used and have concerns, contact your healthcare provider for further guidance.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Xstar Safety Slit Knife, 2.75 mm 45° Bevel Up

Model / REF:

378227

UPC Codes:

00886158001652

Lot Numbers:

6058854

Product: Xstar Safety Slit Knife (Component of CustomEye Kits 584562, 5800109)

Model / REF:

378227

584562

5800109

UPC Codes:

00886158001652

Lot Numbers:

6058854

6068524

6068025

6068285

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94645

Status: Active

Manufacturer: Beaver Visitec International, Inc.

Sold By: authorized medical distributors

Manufactured In: United States

Units Affected: 2 products (1300 units; 126 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected products by checking for Xstar Safety Slit Knife (Model 378227) with UDI-DI 00886158001652 and Lot Number 6058854.

Check your inventory for CustomEye Kits with numbers 584562 (lots 6068524, 6068025) or 5800109 (lot 6068285).

If you possess an affected knife or kit, immediately stop using the product and set it aside to prevent use in surgical procedures.

Contact Beaver Visitec International, Inc. at their Waltham, Massachusetts location or through their official website to receive instructions on returning the defective products or obtaining replacements.

If you have already undergone a procedure where this device was used and have concerns, contact your healthcare provider for further guidance.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.