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Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material ...

FDA Device Recall #Z-2641-2024 — Class II — June 3, 2024

Recall Summary

Recall Number Z-2641-2024
Classification Class II — Moderate risk
Date Initiated June 3, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Microtek Medical Inc.
Location Saint Paul, MN
Product Type Devices
Quantity 163 cases (8,150 units)

Product Description

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 Pattern

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

Lot / Code Information

SKU/UDI-Device Identifier: 2004S/00748426002498; Lot Numbers: 200328,220321,220321,221220,221220,221102,220321,181127,220321,210506,200328,181127,200328,181127,181127,181127,200328,200328,180625,191113,220321,220321,220321,220321,210506,210506,210109,191113,200328,201115,200328,181127,181127,200328,181127,181127,181127,210506,191113,191113,180625,181127,221220,221102,220321,181127,220321,210506,210506,191113,200328,220321,220321,220321,200328,220321,220321,210506,210506,221220,221102,220321,180625,210109,191113,181127,210506,210506,181127,200328,200328,180625,180625,180625,181127,181127,180625,200328,191113,191113,181127,191113,200328,200328,220321,220321,220321,210506,210506,210506,210506,210109,200328,200328,200328,200328,200328,200328,200328,191113,181127,181127,200328,181127,181127,181127,181127,181127,200328,191113,191113,181127,180625,181127,221220,200328,181127,181127,200328,220321,220321,200328,210506,210506,210506,210506,210109,210109,201115,191113,200328,200328,200328,200328,200328,181127,181127,181127,180625,180625,181127,200328,191113,180625,181127,180625,181127,181127,181127,221220,221220,221220,221220,221220,221220,221102,221102,221102,221102,221102,221102,221102,220321,220321,220321,220321,220321,220321,220321,220321,200328,200328,181127,181127,200328,181127,200328,191113,200328,191113,191113,220321,220321,220321,220321,220321,210506,210506,210506,210506,210506,210506,210506,210506,210506,210506,210109,210109,191113,200328,200328,200328,200328,200328,200328,181127,181127,200328,181127,200328,191113,181127,180625,200328,181127,191113,200328,181127,181127,181127,220321,210506,210109,200328,200328,191113,200328,181127,221220,221102,220321,200328,181127,180625,180625,191113,200328,200328,221102,220321,220321,191113,181127,181127,181127,210109,210109,200328,200328,200328,181127,221102,221220,221220,221220,221102,221102,221102,220321,220321,220321,181127,200328,200328,181127,181127,200328,181127,220321,210506,210506,210109,200328,200328,200328,200328,200328,200328,181127,181127,191113,181127,191113,200328,180625,180625,200328,181127,180625,181127,200328,220321,181127,221220,221220,221220,221220,221220,221220,221220,221220,221220,221102,221102,221102,221102,220321,220321,220321,220321,220321,220321,181127,210109,191113,191113,181127,220321,181127,191113,220321,200328,181127,221220,221220,220321,191113,191113,220321,191113,191113,200328,210109,210109,201115,201115,210109,200328,200328,191113,181127,181127,210506,221220,221220,221220,221220,221220,221220,221220,221220,221102,221102,220321,220321,220321,200328,221220,221102,180625,181127,181127,180625,191113,210506,210109,191113,200328,181127,200328,181127,180625,200328,221220,221220,221220,221102,221102,221102,220321,220321,220321

Other Recalls from Microtek Medical Inc.

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Z-2640-2024 Class II Bag Decanter II, REF 2002S. Packaged on a form,... Jun 3, 2024
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Z-2639-2024 Class II C-Flow Bag Decanter, REF 2000S. Packaged on a f... Jun 3, 2024
Z-2643-2024 Class II Transfer Device, REF 2008S. Packaged on a form,... Jun 3, 2024
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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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