FDA recall Z-2501-2021

Product

Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

Reason for recall

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

Distribution

U.S. Nationwide distribution in the state of WA. O.U.S.: N/A

Key facts

Status

Ongoing

Initiation date

2021-07-08

Report date

2021-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2501-2021