SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual waf...

FDA Device Recall #Z-1134-2022 — Class II — April 22, 2022

Recall Summary

Recall Number Z-1134-2022
Classification Class II — Moderate risk
Date Initiated April 22, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ConvaTec, Inc
Location Greensboro, NC
Product Type Devices
Quantity 600 market units

Product Description

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

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 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.

Lot / Code Information

Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189

Other Recalls from ConvaTec, Inc

Recall # Classification Product Date
Z-0160-2026 Class II DuoDERM" Extra Thin dressings are highly flexib... Aug 29, 2025
Z-0903-2025 Class II Esteem Synergy Stomahesive Skin Barrier, part o... Nov 29, 2024
Z-1495-2024 Class II ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in.,... Feb 27, 2024
Z-1350-2024 Class II Convatec EsteemBody Soft Convex, Drainable Pouc... Feb 19, 2024
Z-1276-2024 Class II ConvaTec Natura Stomahesive Post-Operative / Su... Jan 17, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.