CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report

BVI CustomEyes Procedure Packs recalled by Beaver Visitec International

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes, distributed nationwide in the US. The recall was initiated on 26 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 58001622; UDI-DI: 30886158031728; Lot/Batch Number: 6062867, 6072189
Quantity recalled1,029 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2891-2024
FDA event ID
95068
Recalling firm
Beaver Visitec International, Waltham, MA
Classification
Class II
Status
Ongoing
Recall initiated
26 Jul 2024
FDA classified
28 Aug 2024
Reported
4 Sep 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

26 Jul 2024Recall initiated by company
28 Aug 2024Classified by FDA+33 days
4 Sep 2024Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Part Number: 58001622; UDI-DI: 30886158031728; Lot/Batch Number: 6062867, 6072189

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 95068

This product is part of a recall event; the main page for the event is BVI CustomEyes Procedure Packs recalled by Beaver Visitec International.

ReportedClassRecallCompanyReasonWhere
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
CLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide

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DeviceCLASS IIBVI CustomEyes Procedure Packs recalled by Beaver Visitec InternationalBeaver Visitec InternationalOtherNationwide
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