Baxter Healthcare Corporation: Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.

Hazard

Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

Details from the source

Reason for recall: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions. Distribution: US Nationwide Quantity: 524,376 devices Lot/code info: UDI: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes

UPC codes

07332414064549, 07332414064556

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.