PlainRecalls
FDA Devices Moderate Class II Ongoing

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape

Reported: November 30, 2022 Initiated: October 6, 2022 #Z-0258-2023

Product Description

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, 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.

Details

Recalling Firm
3M Healthcare Business
Units Affected
43,200 units
Distribution
Worldwide distribution.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape. Recalled by 3M Healthcare Business. Units affected: 43,200 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 30, 2022. Severity: Moderate. Recall number: Z-0258-2023.