FDA recall Z-1122-2021

Product

Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Reason for recall

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2020-12-30

Report date

2021-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1122-2021