The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

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