Class 2 Device Recall FethRKath Catheter

• Date Initiated by Firm: February 01, 2021
• Create Date: March 18, 2021
• Recall Status: Terminated on October 17, 2022
• Recall Number: Z-1276-2021
• Recall Event ID: 87333
• 510(K)Number: K954584
• Product Classification: Catheter, conduction, anesthetic - Product Code BSO
• 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
• Code Information: Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049
• Recalling Firm/ Manufacturer: Epimed International, Inc.; 141 Sal Landrio Dr; Johnstown NY 12095-3835
• For Additional Information Contact: Bobbi Harrington; 518-848-3914 Ext. 1400
• Manufacturer Reason for Recall: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
• FDA Determined Cause: Process control
• Action: Epimed issued an " URGENT: MEDICAL DEVICE RECALL" letter on 2/1/21via US Mail. Letter states reason for recall, health risk and Actions to be taken by the Customer/User: " Immediately examine your inventory and quarantine product subject to recall. o In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. " Your notification to your customers may be enhanced by including a copy of this recall notification letter. " Once the product has been quarantined, please complete the Recall Response Form in its entirety- indicating product quantity/disposition, and return the enclosed response form as soon as possible. Epimed Contact Information: In addition, please contact our Sales Administrative Assistant, Bobbi Harrington at (518) 848-3914 or bobbih@epimed.com, so that we can arrange for replacement or credit of the affected product. Contact hours are from 6:00am - 4:00pm EST.
• Quantity in Commerce: 5835 units
• Distribution: US Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BSO