| Class 2 Device Recall Epidural Catheter Set |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = BSO
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