Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Check against the official notice below — it lists the full affected range.
Maquet Cardiovascular, LLC is recalling the Ultima Activator II Reusable Drive Mechanism (part #C-UA-5001, labeled REF UA-5001) due to potential corrosion on the device's pins. The corrosion could pose risks of allergic reaction, metal toxicity, and other delayed health responses. A total of 60 units have been distributed worldwide, including to medical facilities in multiple U.S. states (Alabama, Arizona, California, Florida, Illinois, Kentucky, Louisiana, Missouri, Montana, New Mexico, Ohio, Pennsylvania, Texas, and Wisconsin) as well as Germany, South Korea, Russia, Thailand, and the United Arab Emirates.
The affected devices are from three specific lots: 25153700, 25157489, and 25158616, which are identified on device packaging. If packaging has been discarded, affected devices can be identified by Device Component Lot number 200501, which is etched onto all three device components on the side of the handle and on the underside above each pin. The recall record does not specify a remedy.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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 Lot/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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.