Lower risk Medical device recall · FDA · Published July 22, 2021

Baxter Prismaflex Membrane Recall: Sterilization Risk

Baxter recalls Prismaflex HF 1000 PAES membrane (lot 20B2330M) due to potential unsterilized products affecting medical treatments. Affected users should contact Baxter for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2379-2021Medical device Baxter ›

Lower-risk 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

Take action

Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625

✎ GovInfoNow plain-language explainer

Baxter is recalling a specific medical membrane used in dialysis equipment because some units may not have been properly sterilized. This could lead to infections or other complications during medical treatments. Read more at govinfonow.com/recall/62170-baxter-prismaflex-membrane-recall-sterilization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62170-baxter-prismaflex-membrane-recall-sterilization-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2379-2021

Cite this page

“Baxter Prismaflex Membrane Recall: Sterilization Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62170-baxter-prismaflex-membrane-recall-sterilization-risk. Based on FDA recall #Z-2379-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2379-2021%22&limit=1).

Baxter Healthcare Corporation recalled Baxter prismaflex, HF 1000 PAES membrane (REF 107140) on July 22, 2021, because products labeled as sterile may not have been sterilized. The Food and Drug Administration announced the Class II recall.

How to tell if you have it

Baxter prismaflex, HF 1000 PAES membrane
REF 107140
Lot Numbers: 20B2330M

The hazard

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

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls include a PRO+ MRS SURFACE FOR VERSACARE mattress recall (Aug. 18, 2026), a 0.9% Sodium Chloride Injection recall (Aug. 17, 2026), and a Dextrose 2000mL Bags recall (Aug. 17, 2026). Other recent recalls of similar products include a Medtronic DLP Retrograde Cannula recall (April 21, 2026), a Bayer Stellant FLEX Syringe Kit recall (July 31, 2026), and a Medline Convenience Kits recall (Jan. 7, 2026).

How to tell if you have this one

Check for the lot number 20B2330M on the Baxter Prismaflex HF 1000 PAES membrane used with Prismaflex or PrisMax control units for dialysis treatments.

Brand
Baxter
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2378-2021	Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.; a) 106696, Lot Numbers: 20B2329M b) 106697, Lot Numbers: 20B2323M, 20B2328M (expanded to include 20B2326M) Expansion: c) 107144, Lot Number 20B2325M d) 115307, Lot Number 20B2321M e) 115309, Lot Number 20B2310M and 20F0201 f) 955467, Lot Numbers 20A2604M, 20A2606M, 20A2607M, 20A2608M, 20B2331M, 20B2332M, 20B2333M, 20B2334M, 20B2335M, 20B2336M, 20B2347M, 20A2605M g) 955468, Lot Numbers 20A2602M, 20A2603M, 20B2308M, 20B2311M, 20B2312M, and 20B2324M h) 955595, Lot Numbers 20A2609M, 20A2610M, 20B2337M, 20B2338M, 20B2339M, 20B2340M, 20B2341M, 20B2342M, 20B2343M, 20B2344M, 20B2345M, and 20B2346M i) 955596, Lot Numbers 20A2601M, 20B2302M, and 20B2309M	64275 units
Z-2379-2021	Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.; Lot Numbers: 20B2330M	1976 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number 20B2330M on the membrane packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Jul 22, 2021Firm started the recall
Aug 27, 2021FDA classified it Class II
Sep 8, 2021Published in FDA’s Enforcement Report
Jan 17, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this dangerous for patients?

The recall indicates a potential risk of infection or complications during medical treatments, but the exact danger level is not clearly stated.

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Link to this recall

<a href="https://govinfonow.com/recall/62170-baxter-prismaflex-membrane-recall-sterilization-risk">Baxter Prismaflex Membrane Recall: Sterilization Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2379-2021 (July 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2379-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.