PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 10, 2020 Initiated: April 17, 2020 #Z-2196-2020

Product Description

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.

Reason for Recall

Potential disconnection of tubing set.

Details

Units Affected
4,065
Distribution
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
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corporation. Units affected: 4,065.
Why was this product recalled?
Potential disconnection of tubing set.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2196-2020.