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Getinge Usa Sales Inc Recall 90250

Description: Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700

Getinge Usa Sales Inc Recall 90250 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1278-2022
Event ID90250
Event DescriptionFlow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Product TypeDevices
DistributionUS Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Quantity17 units US
Recall ReasonPotential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Device Classification20220629
Device Code InfoUDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)
Center Classification Date20220623
Recall Initiation Date20220502
Recalling FirmGetinge Usa Sales Inc
Initial Notification Letter
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