Z-1433-2024 Class II Ongoing
FDA device recall Z-1433-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Feb 23, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 440 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 440 units
Product Description
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Code Information
UDI/DI 00653160294453 (case), 10653160294450 (unit), Lot Numbers: 2023090190, 2023101190
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1433-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026