Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Reported: June 29, 2022 Initiated: May 2, 2022 #Z-1278-2022
Product Description
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.
Details
- Recalling Firm
- Getinge Usa Sales Inc
- Units Affected
- 17 units US
- Distribution
- US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700. Recalled by Getinge Usa Sales Inc. Units affected: 17 units US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 29, 2022. Severity: Critical. Recall number: Z-1278-2022.
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