BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled
Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing defective Sol-M syringes. About 1,756 units were distributed nationwide due to manufacturing defects.
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: Defective medical syringes represent risk-of-harm products with potential for medication delivery errors. Although no illnesses or injuries have been reported, the FDA Class II classification reflects identified manufacturing defects in a critical medical device.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000867). Approximately 1,756 units have been distributed nationwide in the United States. The affected lot numbers are 6054595, 6064075, 6071826, and 6075095.
The recall is voluntary and addresses manufacturing defects in low dead space and luer slip tip syringes produced by Sol-Millennium Medical, Inc. These syringes are component parts of BVI CustomEyes Procedure Packs used in medical procedures.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 1,756
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 (6)
- Part Number: 58000867
- UDI-DI: 30886158020753
- Lot/Batch Number: 6054595
- 6064075
- 6071826
- 6075095
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 →Related recalls
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