Agency classClass IIOur severity:High FDA (Devices)·Z-2379-2021·Announced 2021-09-08

Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure

Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device used in critical care (renal replacement therapy) for vulnerable hospitalized patients. Products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. While no injuries or deaths have been reported in the source text, non-sterile dialysis membranes present a significant risk of infection. This meets the rubric criterion for 'High' severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is recalling Prismaflex HF 1000 PAES membranes (REF 107140) used in continuous renal replacement therapy with Prismaflex and PrisMax control units. The recall affects 1,976 units distributed nationwide in the United States with Lot Number 20B2330M.

Products were labeled and sold as sterile but may not have been sterilized. Baxter confirmed that Steril Milano, the sterilization contractor, observed manufacturing nonconformances that were not reported to Baxter. Additionally, sterilization data was manipulated to appear to meet quality standards.

Patients and healthcare providers using these dialysis membranes may be at risk of infection if the devices were not properly sterilized. The U.S. Food and Drug Administration (FDA) has classified this as a Class II recall and is overseeing the recall action.

The recalled product

Product: Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis / Renal Replacement Therapy
Hazard: sterility-failure
infection-risk
Affected units: 1,976

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Numbers: 20B2330M

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · sterility failure