PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 24, 2021 Initiated: February 1, 2021 #Z-1276-2021

Product Description

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

Details

Units Affected
5835 units
Distribution
US Nationwide distribution
Location
Johnstown, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Epimed International, Inc.. Units affected: 5835 units.
Why was this product recalled?
Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Which agency issued this recall?
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1276-2021.