Recall archive / FDA device enforcement
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of p... — FDA record Z-1278-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 2, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 17 units US
- Agency-reported status
- Terminated
- Source record identifier
- Z-1278-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 29, 2022
- Recall initiation date
- May 2, 2022
- Center classification date
- Jun 23, 2022
- Termination date
- Aug 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.