FDA recall Z-0082-2023

Product

Prismaflex M Set: M150 (product code 109990). 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-0082-2023