Baxter Healthcare Corporation: Medical Device Recall in 2021 - (Recall #: Z-2379-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

Product Classification:

Class II

Date Initiated: July 22, 2021

Date Posted: September 8, 2021

Recall Number: Z-2379-2021

Event ID: 88351

Reason for Recall:

Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming

Status: Terminated

Product Quantity: 1976 units

Code Information:

Lot Numbers: 20B2330M

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated