Agency classClass IIOur severity:Severe FDA (Devices)·Z-1280-2021·Announced 2021-03-31

Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability

Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall, which corresponds to a 'Severe' severity score under the rubric, particularly given the critical nature of the medical device used for renal replacement therapy.

Plain-English summary

Baxter Healthcare Corporation is recalling 35,175 Preventative Maintenance Kits (G5010007) and spare part kits (G5064801 and G5006203) for Prismaflex Control Units. These products are used for Continuous Renal Replacement Therapy (CRRT). The recall covers all serial numbers.

The recall was initiated because variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly may lead to alarm situations during or after a system self-test. The agency has classified this as a Class II recall.

The affected products were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam) and numerous international locations. Healthcare facilities and users should stop using the affected kits and contact Baxter Healthcare for further instructions.

The recalled product

Product: Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Dialysis Equipment
Hazard: performance-variability
alarm-situation
Affected units: 35,175

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)

all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · performance variability