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

FDA device recall Z-0004-2014 · posted 2013-10-01 · Terminated

Recall details

Recalling firm

ASO, LLC

Reason for recall

No antibacterial bandages were packed in boxes labeled as antibacterial.

Action taken

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

MXE

Quantity affected

37 cases (72 retail boxes in each case)

Distribution

Distributed in the states of ID, WI, IN, and NE.

Date initiated

2013-08-21

Date posted

2013-10-01

Date terminated

2014-08-04

Location

Sarasota, FL