—#210181

Product

Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit

FDA product code: OFX — General Purpose Dental Tray
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: UDI/DI 40195327120420 (each), 10195327120429 (case), Lot Numbers: 24ABF266

Why it was recalled

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Timeline

Recall initiated: 2024-09-04
Posted by FDA: 2024-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.