Getinge Usa Sales Inc: Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

Is my product affected?

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

• UPC 07325710010457

Check against the official notice below — it lists the full affected range.

What happened

Getinge Usa Sales Inc is recalling 47 units of the Flow-e Anesthesia System (product code 6887900) distributed in Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia. The anesthesia system is used to administer anesthesia while controlling a patient's entire ventilation. A crack may form on the on/off switch of the suction unit, which could result in the switch breaking and preventing the suction unit from being activated, creating an unreasonable risk of harm to patients.

The affected units have specific serial numbers ranging from 50012 to 50132, with UDI-DI 07325710010457. The recall source does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential 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.

Details from the source

Reason for recall: Potential 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. Distribution: US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia Quantity: 47 units US Lot/code info: UDI-DI: 07325710010457 Serial Numbers: 50012, 50013, 50014, 50015, 50016, 50017, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50061, 50062, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132. (Note: UDI was corrected July 7, 2022)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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