FDA recall Z-2641-2024

Microtek Medical Inc. · Class II · device

Product

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).

Reason for recall

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

Distribution

Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.

Key facts

Status
Ongoing
Initiation date
2024-06-03
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2641-2024