FDA recall Z-0263-2023

Product

3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape

Reason for recall

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-10-06

Report date

2022-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0263-2023