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U.S. Department of Health and Human Services

Class 2 Device Recall VersaKath MiniKit

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  Class 2 Device Recall VersaKath MiniKit see related information
Date Initiated by Firm June 18, 2019
Create Date July 24, 2019
Recall Status1 Terminated 3
Recall Number Z-2069-2019
Recall Event ID 83247
510(K)Number K023140  
Product Classification Catheter, conduction, anesthetic - Product Code BSO
Product Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
Code Information Lot 31129344 Exp: 2023-06-30
Recalling Firm/
Manufacturer		 Epimed International, Inc.
141 Sal Landrio Dr
Crossroads Business Park
Johnstown NY 12095-3835
For Additional Information Contact Bobbi Harrington
518-848-3901 Ext. 1200
Manufacturer Reason
for Recall		 Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
FDA Determined
Cause 2		 Labeling mix-ups
Action On June 19, 2019 , the firm mailed a lot specific, medical device market correction letter, via USPS to consignees who received the affected product(s). The letter asked customers to do the following: 1. Please examine your inventory and quarantine any product subject to the recall immediately. 2. Once product has been Quarantined, please complete and return the response form as soon as possible. 3. Please contact EPIMED sales administrative assistance, Bobbi Harrington at (518) 725-0209 ext. 1200 or bobbih@epimed.com, so that immediate replacement or credit for the affected product can be arranged. 4. If you have any questions, please contact Mr. Kris Knapp at 1-800-866-3342 ext. 1305.
Quantity in Commerce 98 kits
Distribution Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
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 = EPIMED INTERNATIONAL, INC.
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