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Recall Observatory FDA recall evidence

Device product

ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

Z-0723-2023

November 15, 2022

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 91081
Status
Ongoing
Classification
Class II
Quantity
5300 devices
Official record key
device-enforcement:Z-0723-2023

Official wording

Reason: ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.

Code information: REF number 420861, Batch 1C03858, exp 01 Mar 2023

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.