APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Syst

FDA device recall Z-2129-2011 · posted 2011-05-03 · Terminated

Recall details

Recalling firm

Baxter Healthcare Renal Div

Reason for recall

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 taken

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.

Root cause

Other

Status

Terminated

Product code

FKX

Quantity affected

N/A

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,

Date initiated

2011-03-16

Date posted

2011-05-03

Date terminated

2012-03-08

Location

Park, IL

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