FDAFDA · Food and drugs·Recall number Z-3189-2024
Stainless Steel Sims Uterine Sound, Part Number 64-601
Published October 2, 2024 · Recall initiated: July 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During the manufacturing process the devices were laser-marked with the incorrect part number.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
- Lot
- UDI-DI: 00888937017779; Part Numbers: 64-600
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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