The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2908-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes (129 units distributed nationwide). The recall was initiated voluntarily due to an issue with the syringes.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary Class II medical device recall with no reported illnesses or injuries. The voluntary nature and absence of reported harm indicate a precautionary approach consistent with Moderate-severity recalls.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip 1ml syringes, Part Number 58001721, Lot Number 6063578. A total of 129 units were distributed nationwide.

The recall was initiated voluntarily in response to an issue with the Sol-M syringes included in the procedure packs. The specific nature of the defect or hazard is not detailed in the FDA recall notice.

Healthcare facilities, eye surgery centers, and medical professionals using these procedure packs are potentially affected. Any remaining units with the identified lot number should be discontinued from use.

Patients and healthcare providers should contact Beaver Visitec International or the FDA with questions regarding the recall or if they have used affected products.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001721;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical / Syringes
Hazard
Affected units
129

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 (3)

  • Part Number: 58001721
  • UDI-DI: 30886158032121
  • Lot/Batch Number: 6063578

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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