The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2864-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The voluntary recall affects approximately 1,629 units distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for syringes used in medical procedures. Although no illnesses or injuries have been reported, the recall indicates a product issue with inherent risk of harm during medical use, meeting the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs, Part Number 58001376, because they contain 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Specifically, the packs contain low dead space and luer slip tip syringes that are the subject of a voluntary recall by Sol-M.

Approximately 1,629 units of the affected CustomEyes Procedure Packs have been distributed nationwide. This recall is being conducted on a voluntary basis.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001376;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Syringe
Hazard
Affected units
1,629

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Part Number: 58001376
  • UDI-DI:30886158031919
  • Lot/Batch Number: 6062023
  • 6064080

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 159 products in this recall →

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