Microtek Medical Inc.: Device Recall

Recall #Z-2639-2024 · 06/03/2024

Class II: Risk

Recall Details

Recall Number: Z-2639-2024
Classification: Class II
Product Type: Device
Recalling Firm: Microtek Medical Inc.
Status: Ongoing
Date Initiated: 06/03/2024
Location: Saint Paul, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,366 cases (518,300 units)

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.

Product Description

C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Distribution Pattern

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

Other Recalls by Microtek Medical Inc.

Class II: Risk 04/13/2025

Due to non-sterile products being labeled as sterile
Class II: Risk 06/03/2024

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Class II: Risk 06/03/2024

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Class II: Risk 06/03/2024

During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Class II: Risk 06/03/2024

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

View all recalls by Microtek Medical Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.