Z-2379-2021Class II

Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for...

Name: Z-2379-2021 Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for...
Creator: Baxter Healthcare Corporation
Published: 2021-07-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-07-22 / Terminated / root cause: supplier

FDA source

Baxter Healthcare Corporation began a recall of Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement... on 2021-07-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2379-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-22
Posted: 2021-08-27
Terminated: 2024-01-17
Recalling firm: Baxter Healthcare Corporation
Product: Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.
Quantity in commerce: 1976 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: 20B2330M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2379-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2378-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2379-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-27

Product code KDI

K042938Class IIGambro Prismaflex Hf1000 and Hf1400 SetsGambro Renal Products / cleared 2005-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)