HomeChoice Automated PD system and HomeChoice Pro recall
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide…
Why was HomeChoice Automated PD system and HomeChoice Pro recalled?
There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Codes: 5C4471(R), 5C8310(R); Serial Numbers: All serial numbers
- Product
- HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 96,458 systems
- Distribution
- Worldwide Distribution: US (nationwide) Including states of: AK, AL, AR, AZ, CA, CO, CT, DE, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia; and countries of: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Cayman Islands, Chile, Colombia, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
- Recall date
- January 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)