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: 1206 units (packs of 10) Lot/code info: GTIN: 07613327606195 Lot Numbers: 2022111804 2022112902 2022121909 2022121910 2022122603 2022122604
07613327606195
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.