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ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

FDA Recall #Z-0723-2023 — Class II — November 15, 2022

Recall #Z-0723-2023 Date: November 15, 2022 Classification: Class II Status: Ongoing

Product Description

ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

Reason for Recall

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.

Recalling Firm

ConvaTec, Inc — Greensboro, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5300 devices

Distribution

US Nationwide distribution.

Code Information

REF number 420861, Batch 1C03858, exp 01 Mar 2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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