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: 1617 units (packs of 10) Lot/code info: GTIN: 07613327606188 Lot Numbers: 2022111806 2022112802 2022120501 2022120502 2022120503 2022120504 2022120505 2022120701
07613327606188
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.