Gambro Prismaflex Hemodialysis Machine, Catalogue Number… recallZ-0032-2007 · Gambro Renal Products, Inc. · initiated May 16, 2006
Terminated All recalls posted in October 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gambro Renal Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
Consignees were notified by letter on 05/16/2006.
Recall details
- Recall number
- Z-0032-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 16, 2006
- Posted by the FDA
- Oct 12, 2006
- Recalling firm
- Gambro Renal Products, Inc.
- Quantity
- 153 units (US)
- Product code
- KDI
- FDA submissions
- K041005
- Distribution
- Nationwide.
Product description
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Code information (models, lots, serial numbers)
Serial numbers: PA0101 to PA0681.
Other devices under the same FDA submission
2 devices cleared under K041005 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PRISMAFLEX SET M100Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system2 recalls1 death150 reports
- PRISMAFLEX SET M60Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system1 recall9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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