The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal d

FDA device recall Z-1292-2015 · posted 2015-03-18 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.

Action taken

An Urgent Device Correction letter dated 10/16/13 was mailed to dialysis centers and medical facilities. A similar Urgent Device Correction letter dated 10/31/13 was mailed to dialysis home patients. The letters requested for customers to examine their devices to determine if the devices are being recalled. If the devices are on the attached list of recalled devices, the customer is to contact Baxter Technical Services at 1-800-553-6898 (7 days a week, 24 hours a day) to arrange for a swap cycler. The letter further requests that customers complete the attached Customer Reply Form and return it to Baxter by fax or e-mail.

Root cause

Process design

Status

Terminated

Product code

FKX

Quantity affected

75 units (US)

Distribution

Worldwide Distribution-US (nationwide) including the states of AK, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, and WI, and the c

Date initiated

2013-10-16

Date posted

2015-03-18

Date terminated

2017-07-21

Location

Round Lake, IL

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