Device product
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Z-1134-2022
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 90041
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 market units
- Official record key
device-enforcement:Z-1134-2022
Official wording
Reason: Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Code information: Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
Distribution pattern: 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.
Derived failure modes
-
Unknown
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.