Getinge Usa Sales Inc Recall 90250
Description: Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Getinge Usa Sales Inc Recall 90250 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1278-2022 |
| Event ID | 90250 |
| Event Description | Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700 |
| Product Type | Devices |
| Distribution | US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia |
| Quantity | 17 units US |
| Recall 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. |
| Device Classification | 20220629 |
| Device Code Info | 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) |
| Center Classification Date | 20220623 |
| Recall Initiation Date | 20220502 |
| Recalling Firm | Getinge Usa Sales Inc |
| Initial Notification | Letter |
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