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Recall Observatory FDA recall evidence

Device product

Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

Z-0291-2016

June 29, 2015

Class III

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 71818
Status
Terminated
Classification
Class III
Quantity
29355
Official record key
device-enforcement:Z-0291-2016

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide Distribution, District of Columbia, and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.