Flow-c Anesthesia System : intended for use in administering… — Class I medical device recall Z-1278-2022
Terminated recall by Getinge Usa Sales Inc, reported 2022-06-29, distributed in CO, FL, IN, MO, NJ, VA. Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk
| Recall number | Z-1278-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-05-02 |
| Classified | 2022-06-23 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2024-08-06 |
| Distributed | CO, FL, IN, MO, NJ, VA |
| Quantity | 17 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 07325710009765 |
| Serial numbers | 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078 |
| Model numbers | 6887700 |
Product
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1278-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.