Class II
Medical Device Recall: Stainless Steel Sims Uterine Sound, Part Number 64-601
CooperSurgical, Inc. · July 31, 2024
Reason for Recall
During the manufacturing process the devices were laser-marked with the incorrect part number.
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
States Affected
NATIONWIDE
Quantity Affected
657 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3189-2024
Status: ongoing
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