Agency classClass IIOur severity:Severe FDA (Devices)·Z-1854-2014·Announced 2014-07-02

NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.

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 classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where adverse health consequences are a reasonable probability.

Plain-English summary

NxStage Medical, Inc. is recalling 13,474 cases of NxStage Dialysate Sacks (SAK) with Concentrate (REF: SAK-301). These disposables are used with the NxStage PureFlow SL Dialysate Preparation System to prepare dialysate for the NxStage System One. The affected lots are 40279015, 40179163, 40179162, 31279127, 3067903, 3057931, 3057930, 3047933, and 3047928.

The recall was initiated because the SAK Dialysate Concentrate contains aluminum levels that exceed the manufacturer's internal product specifications. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide in the United States and internationally to France, the Netherlands, Spain, Sweden, and the United Kingdom. Users of the NxStage PureFlow SL system should check their inventory for the specific lot codes listed above and discontinue use of any affected units.

The recalled product

Product: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL…
Manufacturer: NxStage Medical, Inc.
Category: Medical Device — Dialysis Supplies
Hazard: aluminum-exposure
Affected units: 13,474

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by NxStage Medical, Inc. 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 8 products in this recall →

Same manufacturer · NxStage Medical, Inc.

See all →

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Same hazard · aluminum exposure