3M Healthcare Business recalls 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape

Recall date

October 6, 2022

Source

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

Recall number

Z-0255-2023

FDA classification

Class II

Brand / firm

3M Healthcare Business

Sold / distributed

Worldwide distribution.

Why it was recalled

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

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

What was recalled

3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape