Devices

Device Recall Integrated Automated PD Set with Cassette

Model / Serial
H13L22013
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
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.
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.
Manufacturer
Baxter Healthcare Corp.
1 Event
- Recall of Device Recall Integrated Automated PD Set with Cassette

Manufacturer

Baxter Healthcare Corp.

Manufacturer Address
Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
Manufacturer Parent Company (2017)
Baxter International
Source
USFDA

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