Class 2 Device Recall VersaKath MiniKit

• Date Initiated by Firm: June 18, 2019
• Create Date: July 24, 2019
• Recall Status: Terminated
• Recall Number: Z-2068-2019
• 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 311291155 for epidural or caudal anesthesia
• Code Information: Lot 31129155, Exp: 2022-12-31
• FEI Number: 1316297
• 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: 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: 200 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