Centurion kits: a) DENTAL INSTRUMENT KIT recall: Sterility Concern
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT…
Why was Centurion kits: a) DENTAL INSTRUMENT KIT recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 2310 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)