ConvaTec product recalled over mold contamination

Recall date

October 26, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ConvaTec, Inc recalls SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended…

Recall number

Z-0525-2018

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

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.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.