Food, drugs, devices › Getinge Usa Sales Inc
Device recall: Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of pati
FDA enforcement event 90250 is a device recall by Getinge Usa Sales Inc of Wayne, NJ, initiated 2 May 2022 and classified Class I, with 2 product records.
FDA defines Class I as 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. 8% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 6 Aug 2024. Initiation: voluntary: firm initiated. Getinge Usa Sales Inc has 17 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Getinge Usa Sales Inc, Wayne, NJ.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1278-2022 | Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700 | 17 units US | Class I | Terminated | 29 Jun 2022 |
| Z-1279-2022 | Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900 | 47 units US | Class I | Terminated | 29 Jun 2022 |
Context
Other enforcement events for Getinge Usa Sales Inc
All 17 events for Getinge Usa Sales Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.