Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK...
FDA Device Recall #Z-0790-2013 — Class II — August 21, 2012
Recall Summary
| Recall Number | Z-0790-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Remel Inc |
| Location | Lenexa, KS |
| Product Type | Devices |
| Quantity | 30 |
Product Description
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).
Reason for Recall
The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.
Distribution Pattern
Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.
Lot / Code Information
Lot 1100699
Other Recalls from Remel Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0331-2023 | Class I | Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Ne... | Oct 20, 2022 |
| Z-0334-2023 | Class I | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negat... | Oct 20, 2022 |
| Z-0330-2023 | Class I | Thermo SCIENTIFIC, Sensititre HPB1, Gram Negati... | Oct 20, 2022 |
| Z-0329-2023 | Class I | Thermo SCIENTIFIC, Sensititre GN7F, Gram Negati... | Oct 20, 2022 |
| Z-0327-2023 | Class I | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram ... | Oct 20, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.