Stainless Steel Sims Uterine Sound, Part Number 64-601
FDA Recall #Z-3189-2024 — Class II — July 31, 2024
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.
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
657 units
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated