Recall Z-0811-2018— NxStage Medical, Inc.

Name: FDA recall Z-0811-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-29

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2018-01-29, terminated 2020-04-03. It names one FDA 510(k) clearance: K140571. Product: NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories. Reason: May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product..

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-29
Terminated: 2020-04-03
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K140571 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·cleared 2014-05-15

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: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories

Reason for recall

May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.

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