FDA-Device2024-08-28Class II
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical Inc.
Hazard
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Sold states
Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
Affected count
163 cases (8,150 units)
Manufactured in
1 Ecolab Pl, Saint Paul, MN, United States
Products
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2641-2024Don'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