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Recall Observatory FDA recall evidence

Device product

Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A

Z-0153-2025

September 04, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95415
Status
Ongoing
Classification
Class II
Quantity
320 units
Official record key
device-enforcement:Z-0153-2025

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: a) DYNJ80370A, UDI/DI 40195327388547 (each), 10195327388546 (case), Lot Numbers: 23LBM330; b) DYNJRA1854A, UDI/DI 40195327117062 (each), 10195327117061 (case), Lot Numbers: 23LBJ089

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