FDA recall Z-1294-2024

Beaver Visitec International, Inc. · Class II · device

Product

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

Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.

Key facts

Status
Ongoing
Initiation date
2024-02-02
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2024