Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
FDA Device Recall #Z-1093-2017 — Class II — April 22, 2016
Recall Summary
| Recall Number | Z-1093-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Acumedia Manufacturers, Inc. |
| Location | Lansing, MI |
| Product Type | Devices |
| Quantity | 482 |
Product Description
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Reason for Recall
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
Lot / Code Information
7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B
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-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.