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Recall Observatory FDA recall evidence

Device product

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000479;

Z-2810-2024

July 26, 2024

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 95068
Status
Ongoing
Classification
Class II
Quantity
162 units
Official record key
device-enforcement:Z-2810-2024

Official wording

Reason: 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.

Code information: Part Number: 58000479; UDI-DI: 30886158019108; Lot/Batch Number: 6071531, 6073788

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.