FDA Device recall Z-1134-2022
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers
- FDA Device
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers by Convatec, citing firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1134-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-22 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Convatec |
| Distribution | US |
Product
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
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.
Identifiers
| code_info | Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2022%22
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