Baxter Healthcare Corp.

H13L22013

Gastroenterology-Urology Devices

2

No

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.

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.

Lot numbers: UR13125045, UR13126035, UR13126043, UR13K22031, UR131L06024, UR13L09077, UR13L10042, UR13L17047, UR14A17048, UR14A21057, UR14B05017, UR14B26039, UR14C06039, UR14C13068, UR14C27035, UR14D15046, and UR14E20043

Gastroenterology-Urology Devices

2

No

US Distribution.

Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC || Plastic Containers, Approximate Length 85" (2.2 m)

Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

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

Gastroenterology-Urology Devices

2

No

Nationwide Distribution, District of Columbia, and Puerto Rico.

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

Lot Numbers: GR323998, GR325035, GR326082, and GR327965

General Hospital and Personal Use Devices

2

No

US Nationwide Distribution and the country of Canada

Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, || Product Usage: || C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.