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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62528
Product Type Devices
Status Ongoing
Recalling Firm Baxter Healthcare Renal Div
City Waukegan
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. all lots and serial numbers Class II 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. N/A Z-2132-2012