Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Reason for recall: Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications Distribution: US Nationwide distribution. Quantity: 1979 units (packs of 10) Lot/code info: GTIN: 07613327606171 Lot Numbers: 2022111805 2022112801 2022112803 2022112804 2022112805 2022112806 2022112807 2022112808 2022120506 2022120507 2022120508
07613327606171
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.