Notice was issued to clarify flow rates related to the inlet fluid temperature.
Reason for recall: Notice was issued to clarify flow rates related to the inlet fluid temperature. Distribution: US (nationwide) and Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reuni Quantity: 186,880 units Lot/code info: UDI/DI 50707387792720 (box), 10707387792722 (pouch, )SKU 7100235070, All lots with a manufacturing date after March 2022
50707387792720, 10707387792722
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.