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.
Reported: February 11, 2015 Initiated: December 8, 2014 #Z-1039-2015
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.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 8,640 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corp.. Units affected: 8,640 units.
Why was this product recalled? ▼
Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1039-2015.
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