FDA-Device2022-12-21Class II
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Hazard
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Sold states
US nationwide distribution, and Canada.
Affected count
80 kits
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief