FDA-Device2020-01-01Class II
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
3M Company - Health Care Business
Hazard
While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.
Sold states
Nationwide, Canada, Germany, France, Switzerland, Denmark
Affected count
470,954 rolls
Manufactured in
3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, United States
Products
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0719-2020Don't want to check this manually?
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