FDAFDA · Food and drugs·Recall number Z-1433-2024
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
Published April 10, 2024 · Recall initiated: February 23, 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
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Lot
- UDI/DI 00653160294453 (case), 10653160294450 (unit), Lot Numbers: 2023090190, 2023101190
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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