Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2024