BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Summary
The FDA issued a Class II for BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syri by Beaver Visitec International, Inc.. Reason: Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes .
Details
Source
Device Recall
External ID
Z-2890-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Lot/Code Info: Part Number: 58001609; UDI-DI: 30886158031544; Lot/Batch Number: 6064451
Quantity Affected: 82 units
Reason for Recall
Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-26
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beaver Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beaver Visitec International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beaver Visitec International, Inc. have FDA actions?
Beaver Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2890-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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