BVI CustomEyes Procedure Packs with Sol-M syringes recalled
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 123 units distributed nationwide.
What this means for you
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 with no reported illnesses or injuries in the source material. Medical devices used in surgical procedures are inherently risk-of-harm products, warranting a High severity rating despite the absence of reported adverse events.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001649) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. Affected units are from lot 6073574.
The specific reason for this voluntary recall is not detailed in the FDA notice. 123 units were distributed nationwide in the United States.
Users of these procedure packs should contact Beaver Visitec International for further instructions regarding the recalled units.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 123
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: 58001649
- UDI-DI: 30886158032053
- Lot/Batch Number: 6073574
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.
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