1) The HomeChoice automated peritoneal dialysis system. recall: Software Issue
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated…
Why was 1) The HomeChoice automated peritoneal dialysis system. 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.
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?
*** 1) HomeChoice automated peritoneal dialysis system: Product Codes: 5C4471 and 5C4471R; Serial Numbers: All serial numbers; *** 2) HomeChoice Pro automated peritoneal dialysis system: Product Codes: 5C8310 and 5C8310R; Serial Numbers: All serial numbers
- Product
- 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan
- Recall date
- August 31, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)