HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems
FDA device recall Z-0939-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- 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.
- Action taken
- The firm, Baxter, sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 6, 2014 to all peritoneal dialysis provider direct accounts. Baxter also sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 9, 2014 to all peritoneal dialysis patient direct accounts The letters described the product, problem and actions to be taken. The letters included instructions for the recipients to complete the attached Customer Reply Form and to return it to Baxter via scanned e-mail to: fca@baxter.com or fax : 224-270-5457. In addition, the letter to patients instructed them to contact their healthcare provider to discuss this issue. Customers with clinical questions should contact Baxter's Renal Division Clinic Helpline at 888-736-2573, option 2 (8:00 AM - 5:00 PM CST). Adverse reaction or quality problems experienced with the use of these product can be reported by contacting Baxter Product Surveillance at 800-437-5176 (Monday - Friday, 8:00 AM - 5:30 PM CST) or e-mail to corporate_product_complaints_round_lake@baxter.com. Customers with general questions about the letter should contact The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST).
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 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,
- Date initiated
- 2014-10-06
- Date posted
- 2015-01-07
- Date terminated
- 2016-03-28
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936) | Baxter Healthcare Corp | 2011-03-30 |