SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
This recall has been terminated (originally issued April 22, 2022).
- Company
- Convatec, Inc
- Recall Initiated
- April 22, 2022
- Terminated
- March 4, 2026
- Recall Number
- Z-1134-2022
- Quantity
- 600 market units
- Firm Location
- Greensboro, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Distribution
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 / Code Info
Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
Root Cause
Under Investigation by firm
Action Taken
The consignee recall notification was sent out via the United Pacel Service on 04/22/2022. The letter instructs the consignee to not use the product and complete the recall response form. The consignee should call the toll-free number to arrange a return.