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Recall Observatory FDA recall evidence

Device product

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

Z-1294-2024

February 02, 2024

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 93951
Status
Ongoing
Classification
Class II
Quantity
3,000 units (US and OUS)
Official record key
device-enforcement:Z-1294-2024

Official wording

Reason: Pack and pouch label is missing the manufacturing and expiration date.

Code information: UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label is missing