Z-1039-2015 Class II Terminated
FDA device recall Z-1039-2015 was initiated by Baxter Healthcare Corp. on Dec 8, 2014 and is designated Class II. Reason for recall: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage. The recall status is terminated (terminated Oct 28, 2015). Affected quantity: 8,640 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 11, 2015
- Initiation Date
- Dec 8, 2014
- Termination Date
- Oct 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,640 units
Product Description
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.
Reason for Recall
Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
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.
Code Information
H13L22013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1039-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026