Agency classClass IIOur severity:High FDA (Devices)·Z-0760-2023·Announced 2022-12-28

Revaclear 400 Dialyzers Recalled for Potential Internal Blood Leaks

Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.

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: FDA Class II recall for a medical device defect with potential for serious harm (internal blood leaks). No illnesses or injuries are reported in the source text, making this a theoretical risk rather than demonstrated harm, which qualifies as a High-severity recall per the rubric.

Plain-English summary

Baxter Healthcare Corporation is recalling 3,610,944 units of Revaclear 400 Dialyzers (Product Code: 114746L) due to a manufacturing defect. The dialyzers are used to treat patients with chronic and acute renal failure through hemodialysis.

The recall was initiated because a twisted gasket in the dialyzer could result in internal blood leaks during treatment. This manufacturing defect creates a potential safety hazard for patients undergoing dialysis.

Affected units were distributed worldwide, including throughout the United States (including Guam and U.S. Virgin Islands), Canada, and over 30 other countries across Europe, Asia, Africa, the Middle East, and the Caribbean. The FDA has identified specific affected lot numbers for this product.

Patients and healthcare providers using Revaclear 400 Dialyzers should verify whether they have affected units and consult with their dialysis center and healthcare provider for guidance on this recall. More information is available from the FDA and Baxter Healthcare Corporation.

The recalled product

Product: Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: blood-leak
gasket-defect
Affected units: 3,610,944

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 (20)

UDI-DI: 07332414124076
Product Code: 114746L
Lot Numbers: C421222601
C421222701
C421222801
C421222901
C421223001
C421223101
C421223201
C421223301
C421223401
C421223501
C421223601
C421223701
C421223801
C421223901
C421224001
C421224101
C421224201
C421224301

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 · blood leak