Reported Aug 31, 2016 · Terminated
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2)…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- 1) The HomeChoice automated peritoneal dialysis system. Dataplate located
- on the device is labeled in partBaxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located
- on the device is labeled in partBaxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis
- Lot codes and dates
- *** 1) HomeChoice
- automated peritoneal dialysis systemProduct
- Codes5C4471 and 5C4471R
- Serial NumbersAll serial numbers; *** 2) HomeChoice Pro
- automated peritoneal dialysis systemProduct
- Codes5C8310 and 5C8310R
- Serial NumbersAll serial numbers
- Amount recalled
- *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units
Where it was sold
- Nationwide
- PR
Why it was recalled
In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.
This product could cause temporary or reversible health problems — stop using it.
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