FDA recall Z-1276-2021

Epimed International, Inc. · Class II · device

Product

Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

Reason for recall

Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

Distribution

US Nationwide distribution

Key facts

Status: Terminated
Initiation date: 2021-02-01
Report date: 2021-03-24
Termination date: 2022-10-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Johnstown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1276-2021