FDA recall Z-0725-2018

Product

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

Reason for recall

The tucking depth feature of this catheter introducer is marginally outside the upper specification.

Distribution

To be added.

Key facts

Status

Terminated

Initiation date

2017-09-12

Report date

2018-03-07

Termination date

2018-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2018