Home / Recalls / Baxter Healthcare Corp. / Z-0291-2016

Z-0291-2016 Class III Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0291-2016 was initiated by Baxter Healthcare Corp. on Jun 29, 2015 and is designated Class III. Reason for recall: 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… The recall status is terminated (terminated Jan 24, 2017). Affected quantity: 29355.

Recall Details

Product Type: Devices
Report Date: Nov 25, 2015
Initiation Date: Jun 29, 2015
Termination Date: Jan 24, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29355

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution, District of Columbia, and Puerto Rico.

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0291-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Baxter Healthcare Corp.

Z-3133-2017 Class II — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (Sep 1, 2017)
Z-0370-2017 Class II — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code… (Oct 12, 2016)
Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA… (Sep 28, 2016)
Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum… (Sep 28, 2016)
Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum… (Sep 28, 2016)
Z-2533-2016 Class II — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product… (Jun 24, 2016)
Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular… (May 12, 2016)
Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular… (May 12, 2016)
Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular… (May 12, 2016)