Flow-c Anesthesia System : intended for use in recall
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number…
Why was Flow-c Anesthesia System : intended for use in 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number…
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- 17 units US
- Distribution
- US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
- Recall date
- June 29, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)