RecallRadar

FDA Device recall Z-0525-2018

SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802

On 2018-02-14 the FDA classified a Class II recall of SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802 by Convatec, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0525-2018
ClassificationClass II
Statusterminated
Initiated2017-10-26
Published2018-02-14
Last updated2026-09-13 11:54 UTC
CompanyConvatec
DistributionUS

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.

Reason

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).

Identifiers

code_infoLot 7H02242

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0525-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.