Class II

Medical Device Recall: Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Microtek Medical Inc. · June 3, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

30,435 cases (1,521,750 units)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2642-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.