Baxter HomeChoice and HomeChoice Pro APD systems recall
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal…
Why was Baxter HomeChoice and HomeChoice Pro APD systems recalled?
Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.
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?
All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R. Dates Distributed: 1994 to present Quantity Distributed: All
- Product
- Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 29355
- Distribution
- Nationwide Distribution, District of Columbia, and Puerto Rico.
- Recall date
- November 25, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)