Z-0887-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
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.
Distribution Pattern
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.
Code Information
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.