Medical Device Recall: Z-0004-2014

FDA Recalls dataset · Firm: ASO, LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-08-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2014.

Recall Res Number
Z-0004-2014
Recalling Firm / Manufacturer
ASO, LLC
FEI Number
1038758
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-08-21
Date Posted
2013-10-01
Date Terminated
2014-08-04
Product Code
MXE
Event Number
66357
Product Quantity
37 cases (72 retail boxes in each case)
Product Description SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Reason for Recall No antibacterial bandages were packed in boxes labeled as antibacterial.
Action Details 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.
Distribution Pattern Distributed in the states of ID, WI, IN, and NE.
Code Information / Serial Numbers UPC Code #: 400129133311 Lot numbers: 330543 and 341383

Related Establishments / Registrations

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