Baxter Healthcare Corporation: Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal repla

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: 1,068,560 devices Lot/code info: UDI: 07332414075682 (product code 107643), 07332414075613 (product code 107636), 07332414075651 (product code 107640); All Lot Codes

UPC codes

07332414075682, 07332414075613, 07332414075651

Source

Official record: FDA (Device enforcement) ↗

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