FDA recall Z-1684-2021

Product

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Reason for recall

There is a potential leak between the venous patient connector and patient's hemodialysis access.

Distribution

Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.

Key facts

Status

Terminated

Initiation date

2021-04-14

Report date

2021-06-02

Termination date

2024-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2021