SUR-FIT NATURA recallZ-1134-2022 · ConvaTec, Inc · initiated Apr 22, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1134-2022
- Status
- Terminated
- Initiated by the company
- Apr 22, 2022
- Recalling firm
- ConvaTec, Inc
- Quantity
- 600 market units
- Product code
- EXE
- 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.
Product description
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Code information (models, lots, serial numbers)
Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SUR-FIT NATURA 413157Convatec, Purchasing Department · Protector, Ostomy1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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