FDA Enforcement
Class II
Ongoing
Stainless Steel Sims Uterine Sound, Part Number 64-601
Recall: Z-3189-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3189-2024
- Event ID
- 95232
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CooperSurgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- July 31, 2024
- Classification Date
- September 20, 2024
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350, United States
Description
Stainless Steel Sims Uterine Sound, Part Number 64-601
Reason
During the manufacturing process the devices were laser-marked with the incorrect part number.
Code Info
UDI-DI: 00888937017779; Part Numbers: 64-600
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Quantity
657 units