Recall Z-0454-2022— Tapemark Company

Name: FDA recall Z-0454-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Class III · Terminated

Class III FDA medical device recall by Tapemark Company, initiated 2021-11-10, terminated 2023-02-01. It names one FDA 510(k) clearance: K992708. 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.. Reason: The dosage information on the pouch is incorrect; the primary carton label is correct..

Recalling firm: Tapemark Company
Classification: Class III
Status: Terminated
Initiated: 2021-11-10
Terminated: 2023-02-01
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K992708 — IONTOPATCHBirch Point Medical, Inc.·cleared 2000-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The dosage information on the pouch is incorrect; the primary carton label is correct.

Data sourced from openFDA. This site is unofficial and independent of the FDA.