FDAClass IINovember 30, 2022

3M Steri-Drape recall

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

Why was 3M Steri-Drape 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI (01)30707387058204, Lot numbers: 33H9HW, 33HXMD, 33JKD4, 33JKLL, 33KPXJ

Product
3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
Recalling firm
3M Healthcare Business
Quantity
36,020 units
Distribution
Worldwide distribution.
Recall date
November 30, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls