Device 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.
Z-0454-2022
Product summary
- Firm
- Tapemark Company
- Event
- Event 89161
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,141 primary cartons
- Official record key
device-enforcement:Z-0454-2022
Official wording
Reason: The dosage information on the pouch is incorrect; the primary carton label is correct.
Code information: Lot numbers 1131-1 and 1131-2
Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.
Derived failure modes
-
Unknown
The dosage information on the pouch is incorrect; the primary carton label is correct.