Recall Z-1858-2014— NxStage Medical, Inc.

Name: FDA recall Z-1858-2014
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-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40. 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-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40

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.