Device product
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Z-2195-2020
Product summary
- Event
- Event 85514
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,800 units
- Official record key
device-enforcement:Z-2195-2020
Official wording
Reason: Potential disconnection of tubing set.
Code information: Product Code: 114434; UDI: 47332414112395; Lot Numbers: 1000201510, 1000206870, 1000214235, 1000218202, 1000224530
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
Derived failure modes
-
Unknown
Potential disconnection of tubing set.