Z-0004-2014Class II

SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns

Name: Z-0004-2014 SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns
Creator: Aso, Llc
Published: 2013-08-21
License: https://open.fda.gov/license/

Aso LLC / initiated 2013-08-21 / Terminated / root cause: labeling and UDI

FDA source

ASO, LLC began a recall of SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns on 2013-08-21. FDA classified it as Class II and gives the reason as "No antibacterial bandages were packed in boxes labeled as antibacterial". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0004-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-21
Posted: 2013-10-01
Terminated: 2014-08-04
Recalling firm: Aso LLC
Product: SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Product code: MXE
Reason for recall: No antibacterial bandages were packed in boxes labeled as antibacterial.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: A letter was sent via e-mail and mail to the only customer on August 23, 2013 that a recall of two lots was in progress and to examine their inventory and stop distribution of the product. Product was to be either place in quarantine or destroyed. A credit for all returned product or by returned completed certificate of destruction.
Quantity in commerce: 37 cases (72 retail boxes in each case)
Distribution: Distributed in the states of ID, WI, IN, and NE.
Product codes and lots: UPC Code #: 400129133311 Lot numbers: 330543 and 341383

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0004-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0004-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-10-01

Product code MXE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)