Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of mic...
FDA Device Recall #Z-2221-2017 — Class III — September 25, 2016
Recall Summary
| Recall Number | Z-2221-2017 |
| Classification | Class III — Low risk |
| Date Initiated | September 25, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Acumedia Manufacturers, Inc. |
| Location | Lansing, MI |
| Product Type | Devices |
| Quantity | 28 units |
Product Description
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Reason for Recall
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Distribution Pattern
Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
Lot / Code Information
PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
Other Recalls from Acumedia Manufacturers, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0283-2019 | Class III | Palcam Agar Base, Acumedia, PN 7669, Product Us... | Aug 2, 2018 |
| Z-0284-2019 | Class III | Campylobacter Blood Free Selective Medium, PN 7... | Aug 2, 2018 |
| 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.