FDAFDA · Food and drugs·Recall number Z-1134-2022
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Published June 1, 2022 · Recall initiated: April 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConvaTec, Inc
- Distributor
- 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.
- Lot
- Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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