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: 165 units Lot/code info: UDI/DI 40195327120420 (each), 10195327120429 (case), Lot Numbers: 24ABF266
40195327120420, 10195327120429
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.