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Recall Observatory FDA recall evidence

Device product

WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)

Z-1499-2023

March 23, 2023

Class II

Product summary

Firm
ASO LLC
Event
Event 91970
Status
Ongoing
Classification
Class II
Quantity
919 cases of 24 units
Official record key
device-enforcement:Z-1499-2023

Official wording

Reason: The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.

Code information: UDI/DI 311917124506; Lot Numbers: 00176259, 00176260, 00176582.

Distribution pattern: US Nationwide Distribution: IL. FL, CA, CT, OH, TX, IL, SC, and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.