FDA recall Z-1287-2018

Product

Arterial Access Tray, introducer catheter; Model: GU-04020

Reason for recall

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

Distribution

US nationwide distribution, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2017-10-26

Report date

2018-04-11

Termination date

2019-12-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1287-2018