Z-0525-2018Class II

SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF...

Name: Z-0525-2018 SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF...
Creator: ConvaTec, Inc
Published: 2017-10-26
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2017-10-26 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec, Inc began a recall of SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector... on 2017-10-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0525-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-26
Posted: 2018-02-05
Terminated: 2023-02-03
Recalling firm: ConvaTec Limited
Product: 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.
Product code: PQE Ostomy Care Kit
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).
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017. The letter identified the affected device and the reason for the recall. The letter also provided instructions for distributors, retailers, and end users. End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control; 2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided; 3.) If customers have any affected product in inventory they are to contact [email protected] or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product.
Quantity in commerce: 47,630 units (4,763 market units, 10 per pack)
Distribution: 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.
Product codes and lots: Lot 7H02242

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0525-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0525-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05

Product code PQE

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)