Z-1431-2024 Class II Ongoing
FDA device recall Z-1431-2024 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: 2310 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2310 units
Product Description
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
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
a) DH760, UDI/DI 20653160237713 (case), 00653160237719 (unit), Lot Numbers: 2023042790; b) 9125ST6, UDI/DI 10653160129257 (case), 00653160129250 (unit), Lot Numbers: 2023060790; c) DH760, UDI/DI 20653160237713 (case), 00653160237719 (unit), Lot Numbers: 2023110990
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1431-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026