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Recall Observatory FDA recall evidence

Device product

Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.

Z-1039-2015

December 08, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 70062
Status
Terminated
Classification
Class II
Quantity
8,640 units
Official record key
device-enforcement:Z-1039-2015

Official wording

Reason: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.

Code information: H13L22013

Distribution pattern: US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.