ConvaTec, Inc: Medical Device Recall in 2018 - (Recall #: Z-0525-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 26, 2017

Date Posted: February 14, 2018

Recall Number: Z-0525-2018

Event ID: 78507

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).

Status: Terminated

Product Quantity: 47,630 units (4,763 market units, 10 per pack)

Code Information:

Lot 7H02242

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.

Voluntary or Mandated:

Voluntary: Firm initiated