Baxter Healthcare Corporation: Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). 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: 328,300 devices Lot/code info: UDI 07332414069254 (product code 107140), 07332414069315 (product code 107142); All Lot Codes

UPC codes

07332414069254, 07332414069315

Source

Official record: FDA (Device enforcement) ↗

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