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U.S. Department of Health and Human Services

Class 2 Device Recall Epidural Catheter Set

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  Class 2 Device Recall Epidural Catheter Set see related information
Date Initiated by Firm December 28, 2017
Create Date August 18, 2021
Recall Status1 Completed
Recall Number Z-2312-2021
Recall Event ID 88317
510(K)Number K981329  
Product Classification Catheter, conduction, anesthetic - Product Code BSO
Product NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Code Information Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)
Recalling Firm/
Manufacturer		 Epimed International
13958 Diplomat Dr
Farmers Branch TX 75234-8805
For Additional Information Contact
972-373-9090
Manufacturer Reason
for Recall		 Potential for stylet to protrude from the distal end of the catheter
FDA Determined
Cause 2		 Process control
Action On about 12/28/2017, Epimed mailed their recall notification letter titled, URGENT Medical Device RECALL, to customers. Those letters were followed up with a telephone call or email containing the letter on about 12/30/2017. The letter explained the issue and hazard and requested that if any potentially affected product remains in the accounts inventory, Epimed will offer to replace/credit the affected product. Each customer was asked to complete and return the RECALL RETURN RESPONSE FORM as soon as possible.
Quantity in Commerce 132 units
Distribution Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
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.
510(K) Database 510(K)s with Product Code = BSO and Original Applicant = EPIMED INTERNATIONAL, INC.
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