Z-3189-2024 Class II Ongoing

Recalled by CooperSurgical, Inc. — Trumbull, CT

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