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FDAFDA · Food and drugs·Recall number Z-1431-2024

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

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
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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