Maquet Cardiovascular, LLC Recall 89744
Description: Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Maquet Cardiovascular, LLC Recall 89744 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0887-2022 |
| Event ID | 89744 |
| Event Description | Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. |
| Product Type | Devices |
| 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. |
| Quantity | 60 |
| Recall Reason | 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. |
| Device Classification | 20220413 |
| Device Code Info | UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 25158616) appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number (200501), which is etched onto all 3 device components on side of handle and on underside above each pin. |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220209 |
| Recalling Firm | Maquet Cardiovascular, LLC |
| Initial Notification | Letter |
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