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Terminated

Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.

FDA Recall Z-0032-2007 · Posted 2006-10-12

Recalling FirmGambro Renal Products, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2006-05-16
Date Terminated2012-01-03
Product Quantity153 units (US)

Reason for Recall

A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

Firm Action

Consignees were notified by letter on 05/16/2006.

Root Cause

Software design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSGambro Renal Products · 2004-10-07

Official Source

View FDA Recall →

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

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