Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the...
FDA Device Recall #Z-2213-2017 — Class III — March 23, 2016
Recall Summary
| Recall Number | Z-2213-2017 |
| Classification | Class III — Low risk |
| Date Initiated | March 23, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Acumedia Manufacturers, Inc. |
| Location | Lansing, MI |
| Product Type | Devices |
| Quantity | 5 units |
Product Description
Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
Reason for Recall
Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.
Distribution Pattern
Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
Lot / Code Information
PN 7471A, Lot 105550F
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-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 |
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.