SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm...
FDA Device Recall #Z-0525-2018 — Class II — October 26, 2017
Recall Summary
| Recall Number | Z-0525-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 26, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ConvaTec, Inc |
| Location | Greensboro, NC |
| Product Type | Devices |
| Quantity | 47,630 units (4,763 market units, 10 per pack) |
Product Description
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
Reason for Recall
A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
Distribution Pattern
Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.
Lot / Code Information
Lot 7H02242
Other Recalls from ConvaTec, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1584-2026 | Class II | Convatec, EsteemBody Drainable Pouch REF:42365... | Feb 16, 2026 |
| Z-1583-2026 | Class II | Convatec, EsteemBody Drainable Pouch REF:42365... | Feb 16, 2026 |
| Z-1582-2026 | Class II | Convatec, EsteemBody Drainable Pouch REF:42364... | Feb 16, 2026 |
| 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 |
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.