Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-0085-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 14, 2022

Date Posted: October 19, 2022

Recall Number: Z-0085-2023

Event ID: 90841

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.

Status: Ongoing

Product Quantity: 29,764 devices

Code Information:

UDI 07332414089443, All Lot Codes

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated