FDA recall Z-1269-2020

Product

Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

Reason for recall

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

Distribution

Worldwide

Key facts

Status

Terminated

Initiation date

2020-01-13

Report date

2020-02-26

Termination date

2021-11-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2020