Gambro Prismaflex Continuous Renal Replacement System… recallZ-0695-2007 · Gambro Renal Products, Inc. · initiated Jan 4, 2007
Terminated All recalls posted in March 2007
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
Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
FDA root cause category: Device Design
What the company is doing
Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.
Recall details
- Recall number
- Z-0695-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 4, 2007
- Posted by the FDA
- Mar 31, 2007
- Recalling firm
- Gambro Renal Products, Inc.
- Quantity
- 153 units (Domestic)
- Product code
- KDI
- FDA submissions
- K041005
- Distribution
- Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
Product description
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
Code information (models, lots, serial numbers)
Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page