COVIDIEN LLC recalls Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary an…

Recall date

August 1, 2018

Source

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

Recall number

Z-0017-2019

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential for product sterility breach due to a compromised or pinched seal defect

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

What was recalled

Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.