Recall Z-2132-2012 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Renal Div
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes rangi
| Date | Aug 2, 2012 (initiated Jul 6, 2012) |
| Status | Terminated |
| Reason | Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette. |
| Root cause | Employee error |
| Action | Baxter Healthcare Corp. sent "Important Product Information" letters dated July 6, 2012 to the affected home patients and their clinicians, via first class mail on the same date. The letter identified the product, problem and actions to be taken. The customers were instructed to refer to the Extraneal and/or Dineal package insert, Directions For Use - Preparation for Administration and the HomeChoice APD Systems At-Home Guide for proper procedures to connect to a solution line. Customers are instructed to retain a copy of the letter. The customers were also requested to complete the attach |
| Quantity | N/A |
| Distribution | Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923065 | BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL Baxter Healthcare Corp, Mar 4, 1994 |