Recall Z-0723-2023— ConvaTec, Inc

Name: FDA recall Z-0723-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-15

Class II · Ongoing

Class II FDA medical device recall by ConvaTec, Inc, initiated 2022-11-15. It names one FDA 510(k) clearance: K123481. Product: ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive. 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..

Recalling firm: ConvaTec, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-15
Firm location: Greensboro, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEConvatec, Inc.·cleared 2013-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.