Z-3188-2024 Class II Ongoing
FDA device recall Z-3188-2024 was initiated by CooperSurgical, Inc. on July 31, 2024 and is designated Class II. Reason for recall: During the manufacturing process the devices were laser-marked with the incorrect part number. The recall status is ongoing. Affected quantity: 468 units.
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
- 468 units
Product Description
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
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: 00888937017762; Part Numbers: 64-600