Agency classClass IOur severity:Severe FDA (Devices)·Z-1278-2022·Announced 2022-06-29

Anesthesia System Suction Switch Crack Recall: Potential Equipment Failure

Getinge is recalling 17 Flow-c Anesthesia Systems due to cracks that may develop on the suction unit's on/off switch, potentially preventing the switch from activating and posing a risk to patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity of 4 per the applicable rules. Although no serious injuries or deaths have been reported, the Class I designation reflects the FDA's assessment of an unreasonable risk of harm.

Plain-English summary

Getinge Usa Sales Inc is recalling 17 units of the Flow-c Anesthesia System (Product Code 6887700) due to a potential safety defect. The systems were distributed to facilities in Colorado, Florida, Indiana, Missouri, New Jersey, and Virginia.

The on/off switch of the suction unit may develop a crack, which could cause the switch to break and prevent the suction unit from activating. This poses an unreasonable risk of harm to patients who require proper suction control during anesthesia and ventilation.

Healthcare facilities and anesthesia providers currently using affected units should stop using the equipment and contact Getinge Usa Sales Inc for guidance on repair or replacement options. Affected units can be identified by their serial numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, and 5078.

The recalled product

Product: Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Manufacturer: Getinge Usa Sales Inc
Category: Medical Device — Anesthesia Equipment
Hazard: equipment-defect
switch-failure
Affected units: 17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

UDI-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)

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Getinge Usa Sales Inc

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