FDA-Device2022-11-30Class II
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
3M Healthcare Business
Hazard
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.
Sold states
Worldwide distribution.
Affected count
504,000 units
Manufactured in
2510 Conway Ave E, N/A, Saint Paul, MN, United States
Products
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0248-2023Don't want to check this manually?
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