Recall Z-0719-2020— 3M Company - Health Care Business
Class II · Terminated
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2019-11-21, terminated 2021-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-21
- Terminated
- 2021-04-23
- Firm location
- Saint Paul, MN, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.