Z-3189-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- July 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 657 units
Product Description
Stainless Steel Sims Uterine Sound, Part Number 64-601
Reason for Recall
During the manufacturing process the devices were laser-marked with the incorrect part number.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Code Information
UDI-DI: 00888937017779; Part Numbers: 64-600