Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction
Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a functional defect that could impact patient treatment, but the source text does not report any specific injuries, illnesses, or fatalities, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corp. is recalling 200 units of the HomeChoice and HomeChoice Pro Automated Personal Cycler, used for automated peritoneal dialysis. The affected product codes are 5C8310, 5C8310R, R5C8320, and 5C4474.
The recall was initiated because the keypad buttons on the devices may be activated without the operator pressing them. This malfunction could potentially interfere with the operation of the dialysis equipment.
The recalled units were distributed between April 15, 2014, and June 11, 2014, to 35 states and the District of Columbia. Consumers and healthcare providers should contact Baxter Healthcare for further instructions on how to address this issue.
The recalled product
- Product
- HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 200
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 (1)
- all codes distributed between 4/15/2014 and 6/11/2014
Distribution
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