Z-1134-2022Class II

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

Name: Z-1134-2022 SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers
Creator: ConvaTec, Inc
Published: 2022-04-22
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2022-04-22 / Terminated

FDA source

ConvaTec, Inc began a recall of SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers on 2022-04-22. FDA classified it as Class II and gives the reason as "Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1134-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-22
Posted: 2022-05-25
Terminated: 2026-03-04
Recalling firm: ConvaTec Limited
Product: SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Product code: EXE Protector, Ostomy
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 600 market units
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 codes and lots: Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1134-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1134-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-25

Product code EXE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)