Skip to content
Recall Observatory FDA recall evidence

Device product

Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit

Z-0159-2025

September 04, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95415
Status
Ongoing
Classification
Class II
Quantity
165 units
Official record key
device-enforcement:Z-0159-2025

Official wording

Reason: 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.

Code information: UDI/DI 40195327120420 (each), 10195327120429 (case), Lot Numbers: 24ABF266

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile product if the vendor seal of the pouch is opened/unsealed