Recall Z-1039-2015
Baxter Healthcare Corp. · initiated December 8, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: H13L22013
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1039-2015
- Initiated
- December 8, 2014
- Posted by FDA
- February 2, 2015
- Terminated
- October 28, 2015
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 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.
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL