BEUDAMED
    FDA Recall Terminated

    APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; 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.

    Recall: Z-2129-2011 · Initiated March 16, 2011

    Recall

    Recall Number
    Z-2129-2011
    Event Number
    58383
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2011
    Posted
    May 3, 2011
    Terminated
    March 8, 2012
    Address
    1620 Waukegan Rd, Mc Gaw Park, IL, 60085-6730

    Description

    APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; 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.

    Reason

    Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 "To reduce the risk of bums, electrocution, fire, or injury to persons: Close supervision is necessary when this product is used by, on, or near children or those unable to care for themselves." Tubing entanglement around the neck may r

    Action

    Baxter sent Safety Alert letters dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to consider the following safeguards for at-risk patients on HomeChoice Therapy: Have a caregiver present while the patient is performing therapy. Move the HomeChoice cycler to the foot of the bed, if possible, to minimize the likelihood of entanglement that may lead to asphyxiation. Install bed railings for patients at risk for seizures or falls from bed. Complete the attached customer reply form and fax it to Baxter at t847-270-5457. For questions regarding this recall call 888-736-2543, option 2.

    Distribution

    Worldwide Distribution - USA including AZ, CA, CT, DC, FL, KY, MO, NC, NM, Ny, OH, PA, TN, TX, and VA and the countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovania, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingom, and Venezuela.

    Quantity

    N/A