Z-1276-2021 Class II Terminated

Recalled by Epimed International, Inc. — Johnstown, NY

Recall Details

Product Type
Devices
Report Date
March 24, 2021
Initiation Date
February 1, 2021
Termination Date
October 17, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5835 units

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

Distribution Pattern

US Nationwide distribution

Code Information

Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049