Z-1294-2024 Class II Ongoing
FDA device recall Z-1294-2024 was initiated by Beaver Visitec International, Inc. on Feb 2, 2024 and is designated Class II. Reason for recall: Pack and pouch label is missing the manufacturing and expiration date. The recall status is ongoing. Affected quantity: 3,000 units (US and OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Feb 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,000 units (US and OUS)
Product Description
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Reason for Recall
Pack and pouch label is missing the manufacturing and expiration date.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
Code Information
UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1294-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026