NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.
FDA Recall Z-1071-04 · Posted 2004-07-20
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Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2004-04-14
Date Terminated2004-07-13
Product Quantity552 units
Reason for Recall
Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate
Firm Action
Voluntary recall notice dated 4/14/04 sent UPS, overnight with signature required to both ICU/CCU (Acute accounts) and Chronic accounts. Firm to remove and replace product that contains a disposable component from a new supplier that has demonstrated to be less reliable resulting in pinhole leaks.
Root Cause
Other
Distribution Pattern
CA, IL, IN, MD, IA, MO, NJ, OH, VT
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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