3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
Summary
The FDA issued a Class II for 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery by 3M Healthcare Business. Reason: During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the pro.
Details
Source
Device Recall
External ID
Z-0258-2023
Action Date
2022-11-30
Status
Ongoing
Category
device
Product Description
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
Lot/Code Info: UDI/DI (01)50707387029352, Lot numbers: 33JPRN, 33JPWY, 33JR98, 33KLEY, 33KLME
Quantity Affected: 43,200 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-06
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3M Healthcare Business has 18 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3M Healthcare Business) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3M Healthcare Business have FDA actions?
3M Healthcare Business has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0258-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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