BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 5810
Summary
The FDA issued a Class II for BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irr by Beaver Visitec International, Inc.. Reason: Pack and pouch label is missing the manufacturing and expiration date..
Details
Source
Device Recall
External ID
Z-1294-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Lot/Code Info: UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926
Quantity Affected: 3,000 units (US and OUS)
Reason for Recall
Pack and pouch label is missing the manufacturing and expiration date.
Distribution
Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-02
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 148 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-1294-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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