Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Check against the official notice below — it lists the full affected range.
Stryker Corporation recalled 5,089 boxes of Stryker High Flow Tube Set with Real-Time Pressure Sensing (model REF 0620-040-680), a sterile, disposable accessory used with the PNEUMO SURE High Flow Insufflator. The heated tube sets were found to be consistently leaking and detaching from the cassette during use. The recalled product was distributed nationwide to medical facilities, including government and military locations, as well as internationally to Argentina, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Saudi Arabia, UAE, and Uruguay.
The affected product can be identified by UDI number 07613327055641 and specific lot numbers ranging from 18G0273 through 56006606. According to the recall record, no remedy has been specified for consumers or healthcare facilities who received this product.
Written by software from the official notice below. Not reviewed by a lawyer.
The heated tube sets were consistently leaking and detaching from the cassette.
Reason for recall: The heated tube sets were consistently leaking and detaching from the cassette. Distribution: Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay. Quantity: 5,089 boxes Lot/code info: UDI - 07613327055641; Lot numbers: 18G0273, 18H0323, 18H0354, 56004327, 56004391, 56004434, 56004478, 56004526, 56004592, 56004665, 56004667, 56004706, 56004708, 56004784, 56004832, 56005325, 56005376, 56005378, 56005380, 56005411, 56005450, 56005459, 56005538, 56005540, 56005633, 56005635, 56005744, 56005790, 56005899, 56005901, 56005989, 56005997, 56005999, 56006142, 56006154, 56006270, 56006340, 56006434, 56006521, 56006527, 56006556, 56006560, 56006606.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.