Baxter HomeChoice Pro APD System Recalled for Occluder Defect
Baxter Healthcare is recalling 75 HomeChoice Pro APD systems because the occluder may have sharp edges or separate, causing system errors or therapy termination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect poses a risk of harm by terminating dialysis therapy, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Baxter Healthcare Corp. is recalling 75 units of the HomeChoice Pro APD System, a peritoneal dialysis system intended for the automatic control of dialysate solution exchange in patients with renal failure. The recall affects devices with Product Code 5C8310 and specific serial numbers listed in the agency record.
The recall was initiated because the occluder in the affected devices may have sharp edges that could cut the pneumatic tubing connecting the occluder blade to the manifold, resulting in an unrecoverable system error. Additionally, the blade may separate from the back plate, causing a Slow / No Flow alarm that requires the termination of therapy.
The affected units were distributed nationwide in the United States, including specific states such as 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, as well as in Australia, Canada, and Mexico. Patients using these devices should contact Baxter Healthcare or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing per
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: 5C8310
- Serial Numbers: 80415
- 680416
- 680418
- 680420
- 680421
- 680422
- 680424
- 680426
- 680427
- 680428
- 680429
- 680430
- 680438
- 680439
- 680440
- 680441
- 680444
- 680445
- 680448
Distribution
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