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Field Safety Notice FA-24-004

To the attention of BVI Customers:

Beaver-Visitec International, Inc. (BVI) has been made aware of a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. As syringes manufactured by Sol-M are present in some of our BVI CustomEyes Procedure Packs, we are voluntarily initiating a recall of these products. Please note that this action is specific to the Sol-M manufactured syringes contained in BVI CustomEyes Procedure Packs – the remaining components of BVI CustomEyes Procedure Packs are unaffected and suitable for use once you have completed the activities described in this letter.


Background
The U.S. Food and Drug Administration (FDA) has issued an updated Field Safety Communication1 for syringes manufactured in China. Citing concerns of quality and safety, FDA recommends that healthcare providers transition away from using plastic syringes manufactured by China-based manufacturers, unless use of these syringes is absolutely necessary until they can complete the transition to syringes that are not manufactured in China. If these syringes continue to be used, users should closely monitor for leaks, breakage, and other problems. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Further, as BVI has been made aware of a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., and as these syringes are present in some BVI CustomEyes Procedure Packs, we are voluntarily initiating a recall of these products.

Please consult the following document to consult affected products and actions required of you: Field Safety Notice FA-24-004

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