FDAFDA · Food and drugs·Recall number Z-2196-2020
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Published June 10, 2020 · Recall initiated: April 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential disconnection of tubing set.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- 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
- Lot
- Product Code: 114435; UDI: 37332414112401; Lot Numbers: 1000212228, 1000215484, 1000224531
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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