Recall Z-0939-2015 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corp.
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have p
| Date | Jan 7, 2015 (initiated Oct 6, 2014) |
| Status | Terminated |
| Reason | There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems. |
| Root cause | Labeling design |
| Action | The firm, Baxter, sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 6, 2014 to all peritoneal dialysis provider direct accounts. Baxter also sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 9, 2014 to all peritoneal dialysis patient direct accounts The letters described the product, problem and actions to be taken. The letters included instructions for the recipients to complete the attached Customer Reply Form and to return it to Baxter via scanned e-mail to: fca@baxter.com or fax : 224-270-5457. In addition, the letter to patients instructed them to contact their healt |
| Quantity | 96,458 systems |
| Distribution | Worldwide Distribution: US (nationwide) Including states of: AK, AL, AR, AZ, CA, CO, CT, DE, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia; and countries of: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp, Mar 30, 2011 |