Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-0081-2023)

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 M Set: M60 (product code 106696), M100 (product code 106697). 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-0081-2023

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: 524,376 devices

Code Information:

UDI: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated