BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes
Beaver Visitec International voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 69 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 recall affecting medical devices used in surgical procedures. FDA Class II indicates products where use may cause temporary or medically reversible adverse health consequences. Although the recall was voluntary and no illnesses or injuries have been reported, defective syringes in surgical procedures represent a risk-of-harm situation.
Plain-English summary
Beaver Visitec International, Inc. has voluntarily recalled BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. The affected procedure packs are identified by Part Number 58000162, with lot numbers 6065820 and 6071739 and a UDI-DI of 30886158018675.
A total of 69 units were distributed nationwide. The source documentation does not specify the nature of the defect in the Sol-M syringes or any reported adverse events.
Healthcare facilities and providers that received these procedure packs should contact Beaver Visitec International for recall instructions and information on replacement products or corrective actions.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- syringe-defect
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: 58000162
- UDI-DI: 30886158018675
- Lot/Batch Number: 6065820
- 6071739
Distribution
Distributed nationwide across the United States.
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