Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Reported: April 13, 2022 Initiated: February 9, 2022 #Z-0887-2022
Product Description
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Reason for Recall
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Details
- Recalling Firm
- Maquet Cardiovascular, LLC
- Units Affected
- 60
- Distribution
- Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.. Recalled by Maquet Cardiovascular, LLC. Units affected: 60.
Why was this product recalled? ▼
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0887-2022.
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