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U.S. Department of Health and Human Services

Class 2 Device Recall FethRKath Catheter

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  Class 2 Device Recall FethRKath Catheter see related information
Date Initiated by Firm February 01, 2021
Create Date March 18, 2021
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MEDIC EVALUATION DEVICES & INSTRUMENTS CORP.
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