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Recall Observatory FDA recall evidence

Device product

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

Z-0004-2014

August 21, 2013

Class II

Product summary

Firm
ASO, LLC
Event
Event 66357
Status
Terminated
Classification
Class II
Quantity
37 cases (72 retail boxes in each case)
Official record key
device-enforcement:Z-0004-2014

Official wording

Reason: No antibacterial bandages were packed in boxes labeled as antibacterial.

Code information: UPC Code #: 400129133311 Lot numbers: 330543 and 341383

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    No antibacterial bandages were packed in boxes labeled as antibacterial.