Recall Z-2132-2012
Baxter Healthcare Renal Div · initiated July 6, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
Codes / lots: all lots and serial numbers
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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 attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Global Technical Services, Renal Technical Support at 1-800-553-6898, option 1, 24 hours a day. For questions regarding this recall call 1-800-422-9837.
Details
- Recall number
- Z-2132-2012
- Initiated
- July 6, 2012
- Posted by FDA
- August 2, 2012
- Terminated
- October 15, 2012
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- N/A
- Distribution
- Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.
- Recalling firm
- Baxter Healthcare Renal Div, Waukegan, IL