Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Summary
The FDA issued a Class II for Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cata by Beaver Visitec International, Inc.. Reason: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades.
Details
Source
Device Recall
External ID
Z-0227-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
Lot/Code Info: LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907. UDI: " Primary: 00886158000594 " Secondary: 30886158000595 " Tertiary: 50886158000599
Quantity Affected: 5950 eaches
Reason for Recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Distribution
Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-08
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 144 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-0227-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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