Prismaflex Control Unit. Dialyzer recall: Software Issue
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients…
Why was Prismaflex Control Unit. Dialyzer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code: 6023014700, 107493, 113081, 115269; Serial Number: All; Affected Software Versions: SW 4.1x, 5.10, 6.10, 7.xx, 8.00
- Product
- Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 3,440 units
- Distribution
- 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
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)