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Terminated

Prismaflex System, Prismaflex Control Unit

FDA Recall Z-1828-2020 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDI
Date Initiated2020-02-06
Date Terminated2021-06-01
Product Quantity4946 units

Reason for Recall

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Firm Action

Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution in US, Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110823PRISMAFLEXGambro Renal Products, Inc. · 2011-06-17K072093PRISMAFLEX SYSTEM, VERSION 3.20Gambro · 2008-02-01

Official Source

View FDA Recall →

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

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