FDA-Device2021-03-24Class II

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

Epimed International, Inc.
Hazard

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

Sold states
US Nationwide distribution
Affected count
5835 units
Manufactured in
141 Sal Landrio Dr, N/A, Johnstown, NY, United States
Products
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

Official notice

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

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