Z-0280-2020 Class II Ongoing
FDA device recall Z-0280-2020 was initiated by Baxter Healthcare Corporation on Oct 4, 2019 and is designated Class II. Reason for recall: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. The recall status is ongoing. Affected quantity: 336 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 13, 2019
- Initiation Date
- Oct 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 336 units
Product description
Reason for recall
Distribution pattern
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, 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, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.
Code information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0280-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026