BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Quality Concern
Beaver Visitec International is recalling 227 units of BVI CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to a quality concern affecting those syringes.
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: FDA Class II classification indicates a device that might cause adverse health consequences. No illnesses or injuries have been reported, and the specific hazard has not been detailed in the source material. This is a voluntary recall initiated in response to a supplier recall.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001838, Lot Number 6069366) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These procedure packs were distributed nationwide across the United States.
The recall was initiated in response to a voluntary recall of Sol-Millennium Medical syringes. The specific nature of the quality concern affecting the Sol-M syringes has not been detailed in this recall notice.
Healthcare facilities and users of these procedure packs should stop using affected units and contact Beaver Visitec International for instructions on returning or disposing of the recalled products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- device-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 (3)
- Part Number: 58001838
- UDI-DI: 30886158033203
- Lot/Batch Number: 6069366
Distribution
Distributed nationwide across the United States.
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