Recall Z-1276-2021— Epimed International, Inc.

Name: FDA recall Z-1276-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-01

Class II · Terminated

Class II FDA medical device recall by Epimed International, Inc., initiated 2021-02-01, terminated 2022-10-17. It names one FDA 510(k) clearance: K954584. 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: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off.

Recalling firm: Epimed International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-02-01
Terminated: 2022-10-17
Firm location: Johnstown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K954584 — RACZ EPIDURAL CATHETERMedic Evaluation Devices & Instruments Corp.·cleared 1996-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.