Recall Z-1856-2014— NxStage Medical, Inc.

Name: FDA recall Z-1856-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-14

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2014-05-14, terminated 2017-03-13. It names 2 FDA 510(k) clearances: K140571, K111174. Product: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.. Reason: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification.

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-14
Terminated: 2017-03-13
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K140571 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·cleared 2014-05-15
K111174 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·cleared 2011-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.

Reason for recall

SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Data sourced from openFDA. This site is unofficial and independent of the FDA.