FDA-Device2022-06-01Class II
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
ConvaTec, Inc
Hazard
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Sold states
Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.
Affected count
600 market units
Manufactured in
7815 National Service Rd Ste 600, Greensboro, NC, United States
Products
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2022Don't want to check this manually?
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