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: 1707 units (packs of 10) Lot/code info: GTIN: 07613327606164 Lot Numbers: 2022111802 2022112904 2022121301 2022121302 2022121905 2022121906 2022121907 2022121908
07613327606164
Official record: FDA (Device enforcement) ↗
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