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.
Recall
- Recall Number
- Z-1039-2015
- Event Number
- 70062
- Firm
- Baxter Healthcare Corp.
- FEI Number
- 1417572
- Product Code
- FKX
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 8, 2014
- Posted
- February 2, 2015
- Terminated
- October 28, 2015
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
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.
Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
Baxter sent an Urgent Product Recall notification letter dated January 8, 2015 . The letter identified the affected product, problem and action to be taken. The recalling firm has asked the consignees to 1) locate and remove all affected product from their facilities, 2) contact Baxter to arrange for return and credit, and 3) complete the attached customer reply form and return it to Baxter. For questions call 800-422-9637.
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.
8,640 units