FDA recall Z-0085-2023

Product

Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

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

Key facts

Status

Ongoing

Initiation date

2022-09-14

Report date

2022-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2023