FDA Medical Device Recalls (openFDA)
ASO, LLC: SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
- Recall number
- Z-0004-2014
- Recalling firm
- ASO, LLC
- Product
- SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
- Status
- Terminated
- Initiated
- 2013-08-21
- Posted
- 2013-10-01
- Terminated
- 2014-08-04
- Reason
- No antibacterial bandages were packed in boxes labeled as antibacterial.
- 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
- 37 cases (72 retail boxes in each case)
- Distribution
- Distributed in the states of ID, WI, IN, and NE.
- Lot, serial or model codes
- UPC Code #: 400129133311 Lot numbers: 330543 and 341383
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MXE
- Firm FEI
- 1038758
- Firm city
- Sarasota
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28