Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving sterile medical devices with potential for loss of sterility. While no illnesses or injuries have been reported, the hazard poses a theoretical risk of infection if the seal fails. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Medline Industries, LP has recalled Centurion dental kits due to weak seals that may compromise sterility. The affected products include Dental Instrument Kits (Product Code DH760) and Sterile Cotton Dental Rolls (Product Code 9125ST6).
The weak seal may result in a breach of sterility if the seal fails during use or storage. The weak seal may not be detectable by visual inspection, so affected units could appear normal while containing non-sterile contents.
2310 units have been distributed worldwide, including the United States, Panama, and Canada. The recall affects healthcare facilities and dental practitioners who have received these products.
The recalled product
- Product
- 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
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-breach
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- a) DH760
- UDI/DI 20653160237713 (case)
- 00653160237719 (unit)
- Lot Numbers: 2023042790
- b) 9125ST6
- UDI/DI 10653160129257 (case)
- 00653160129250 (unit)
- Lot Numbers: 2023060790
- c) DH760
- Lot Numbers: 2023110990
Distribution
Distributed nationwide across the United States.
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