FDA recall Z-1219-2019

Product

CryoPatch SG Pulmonary Hemi-Artery Patch

Reason for recall

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

Distribution

Product was shipped to Texas

Key facts

Status

Terminated

Initiation date

2016-11-21

Report date

2019-05-01

Termination date

2019-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2019