Class 3 Device Recall iontoPATCH

• Date Initiated by Firm: November 10, 2021
• Create Date: January 05, 2022
• Recall Status: Terminated on February 01, 2023
• Recall Number: Z-0454-2022
• Recall Event ID: 89161
• 510(K)Number: K992708
• Product Classification: Device, iontophoresis, other uses - Product Code EGJ
• Product: iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
• Code Information: Lot numbers 1131-1 and 1131-2
• Recalling Firm/ Manufacturer: Tapemark Company; 1685 Marthaler Ln; Saint Paul MN 55118-3517
• For Additional Information Contact: Mr. Beau Garrett; 651-450-5391
• Manufacturer Reason for Recall: The dosage information on the pouch is incorrect; the primary carton label is correct.
• FDA Determined Cause: Labeling Change Control
• Action: Tapemark issued an email on 11/10/2021 to their consignees explaining the pouch dosage is labeled incorrectly as 80 mA/min but the box is labeled correctly with a dosage of 120mA/min. In addition, the patches within the pouch are the 120mA/min patches for the the correct wear time. The email requests the consignee place the affected product on hold and not fill any orders with it, and Tapemark will provide another letter to pass onto their downstream customers who received the affected product to alert them of the mislabeling information. The email goes on to say no corrective action is necessary for their customers since the patch performs as described on the labeled box. On 11/30/2021, Tapemark issued another email to their consignees containing a recall letter dated 30NOV2021 and a subdistributor notification and acknowledgment dated 29NOV2021. The email says Tapemark is recalling the affected lot numbers due to the pouch being labeled incorrectly. Tapemark's consignee is to notify their customers by forwarding the email containing the subdistributor notification and acknowledgment form and to cease distribution. Tapemark's consignee is to let the them, Tapemark, know the quantity sent to the customer and the quantity they have remaining by 12/3/2021. The consignee's customer is to return their remaining inventory to Tapemark. Acknowledgment forms were enclosed with both the consignee letter and the subdistributor letter.
• Quantity in Commerce: 5,141 primary cartons
• Distribution: US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
• 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 = EGJ and Original Applicant = BIRCH POINT MEDICAL, INC.