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Terminated

NxStage Cartridge Express, CAR-170, for hemodialysis.

FDA Recall Z-1228-2007 · Posted 2007-09-20

Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2007-07-27
Date Terminated2010-09-13
Product Quantity12,085 cases

Reason for Recall

Potential for dialysate leaks from the cartridge during treatment.

Firm Action

NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.

Root Cause

Process change control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061837NXSTAGE CARTRIDGE EXPRESSNxstage Medical, Inc. · 2006-07-31K050525NXSTAGE SYSTEM ONENxstage Medical, Inc. · 2005-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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