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Terminated

Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.

FDA Recall Z-1280-2018 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeKDI
Date Initiated2017-02-15
Date Terminated2019-05-08
Product Quantity3,440 units

Reason for Recall

Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.

Firm Action

On February 15, 2017, the firm sent an Urgent Device Correction notification and response form to affected customers via USPS first class mail in order to update software versions of the Prismaflex Control Units. The update was intended to prevent user errors related to the safe unloading of disposable sets. On May 30, 2017, the firm issued an updated notification letter notifying the same customer base of the issue with the programmed syringe sizes. The software update deployed to correct the issue with the safe unloading of disposable sets was also deployed to correct the issue with the programmed syringe sizes. All non-responding customers will be contacted via telephone. Prismaflex control units will be updated to a new software version. For further questions, please call (800) 422-9837.

Root Cause

Use error

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, Iceland, India, Iran, Israel, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine, Vietnam, Yemen, Argentina, Brazil, Chile, and Dominican Republic

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110823PRISMAFLEXGambro Renal Products, Inc. · 2011-06-17

Official Source

View FDA Recall →

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

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