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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama. Quantity: 320 units Lot/code info: a) DYNJ80370A, UDI/DI 40195327388547 (each), 10195327388546 (case), Lot Numbers: 23LBM330; b) DYNJRA1854A, UDI/DI 40195327117062 (each), 10195327117061 (case), Lot Numbers: 23LBJ089
40195327388547, 10195327388546, 40195327117062, 10195327117061
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.