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Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis… recallZ-2132-2012 · Baxter Healthcare Renal Div · initiated Jul 6, 2012

Class II Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Renal Div or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-2132-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 6, 2012
Posted by the FDA
Aug 2, 2012
Recalling firm
Baxter Healthcare Renal Div
Quantity
N/A
Product code
FKX
FDA submissions
K923065
Distribution
Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.

Product description

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.

Code information (models, lots, serial numbers)

all lots and serial numbers

Other devices under the same FDA submission

3 devices cleared under K923065 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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