Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Reason for recall: Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001). Distribution: US, Nationwide Quantity: 4831 units Lot/code info: UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
40080196031765, 10080196031764, 96922110001, 96923100001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.