Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplemen...
FDA Device Recall #Z-0283-2019 — Class III — August 2, 2018
Recall Summary
| Recall Number | Z-0283-2019 |
| Classification | Class III — Low risk |
| Date Initiated | August 2, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Acumedia Manufacturers, Inc. |
| Location | Lansing, MI |
| Product Type | Devices |
| Quantity | 22 bottles |
Product Description
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
Reason for Recall
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Distribution Pattern
Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
Lot / Code Information
Lot 110321B
Other Recalls from Acumedia Manufacturers, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0284-2019 | Class III | Campylobacter Blood Free Selective Medium, PN 7... | Aug 2, 2018 |
| Z-2221-2017 | Class III | Urea Base Agar, Acumedia PN 7226 Urea Agar Bas... | Sep 25, 2016 |
| Z-2212-2017 | Class III | Sabouraud Dextrose Agar w /Lecithin and Tween 2... | Aug 8, 2016 |
| Z-1093-2017 | Class II | Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, ... | Apr 22, 2016 |
| Z-2213-2017 | Class III | Nutrient Gelatin, Acumedia Part Number 7471 A ... | Mar 23, 2016 |
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.