FDA recall Z-0121-2019

Product

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

Reason for recall

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

Distribution

US Nationwide in the state of California.

Key facts

Status

Terminated

Initiation date

2018-09-06

Report date

2018-10-24

Termination date

2020-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2019