FDA Recall
Open, Classified
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
Recall: Z-1431-2024
·
Initiated February 23, 2024
Recall
- Recall Number
- Z-1431-2024
- Event Number
- 94136
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- OFX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 23, 2024
- Posted
- March 29, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
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
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.
Action
Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Quantity
2310 units