PlainRecalls
FDA Devices Moderate Class II Ongoing

BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

Reported: March 20, 2024 Initiated: February 2, 2024 #Z-1294-2024

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.

Details

Units Affected
3,000 units (US and OUS)
Distribution
Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012. Recalled by Beaver Visitec International, Inc.. Units affected: 3,000 units (US and OUS).
Why was this product recalled?
Pack and pouch label is missing the manufacturing and expiration date.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 20, 2024. Severity: Moderate. Recall number: Z-1294-2024.