Z-2195-2020 Class II Terminated
FDA device recall Z-2195-2020 was initiated by Baxter Healthcare Corporation on Apr 17, 2020 and is designated Class II. Reason for recall: Potential disconnection of tubing set. The recall status is terminated (terminated Feb 7, 2023). Affected quantity: 19,800 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 10, 2020
- Initiation Date
- Apr 17, 2020
- Termination Date
- Feb 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,800 units
Product description
Reason for recall
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lithuania, Latvia, Montenegro, Morocco, Netherlands, Norway, Poland, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, Korea, Singapore, Hong Kong
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-2195-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026