FDA recall Z-1099-2019

Product

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Reason for recall

For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

Distribution

US Distribution to states of: IN, MO, and OH.

Key facts

Status

Terminated

Initiation date

2018-09-14

Report date

2019-04-17

Termination date

2022-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2019