Medical device recalls Moderate risk

CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601

Recall date
July 31, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3189-2024
FDA classification
Class II
Brand / firm
CooperSurgical, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.

Why it was recalled

During the manufacturing process the devices were laser-marked with the incorrect part number.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stainless Steel Sims Uterine Sound, Part Number 64-601

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