FDA recall Z-1483-2020

Product

Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.

Reason for recall

The sterile packaging has the potential to be compromised.

Distribution

International distribution of Kuwait City, Kuwait.

Key facts

Status

Terminated

Initiation date

2020-02-06

Report date

2020-03-25

Termination date

2021-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

La Follette, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2020