BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Voluntary Recall
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected syringes are low dead space and luer slip tip models distributed nationwide.
What this means for you
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 medical device recall with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (2).
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs are Part Number 58001818, Lot Number 6075189.
These procedure packs were distributed nationwide in the United States, with 65 units involved in this recall. The recall is voluntary and initiated due to a concurrent recall of the Sol-M syringes contained within the procedure packs.
The specific reason for the syringe recall has not been specified in the public announcement. Further information regarding this recall is available from the FDA and Beaver Visitec International.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 65
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: 58001818
- UDI-DI: 30886158033180
- Lot/Batch Number: 6075189
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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