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Z-1280-2018 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-1280-2018 was initiated by Baxter Healthcare Corporation on February 15, 2017 and is designated Class II. 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… The recall status is terminated (terminated May 8, 2019). Affected quantity: 3,440 units.

Recall Details

Product Type: Devices
Report Date: April 11, 2018
Initiation Date: February 15, 2017
Termination Date: May 8, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,440 units

Product Description

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.

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.

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

Code Information

Product code: 6023014700, 107493, 113081, 115269; Serial Number: All; Affected Software Versions: SW 4.1x, 5.10, 6.10, 7.xx, 8.00

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