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
Product summary
- 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
label is missing