Device product
Stainless Steel Sims Uterine Sound, Part Number 64-601
Z-3189-2024
Product summary
- Event
- Event 95232
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 657 units
- Official record key
device-enforcement:Z-3189-2024
Official wording
Reason: During the manufacturing process the devices were laser-marked with the incorrect part number.
Code information: UDI-DI: 00888937017779; Part Numbers: 64-600
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Derived failure modes
-
Unknown
During the manufacturing process the devices were laser-marked with the incorrect part number.