Z-0719-2020 Class II Terminated
FDA device recall Z-0719-2020 was initiated by 3M Company - Health Care Business on November 21, 2019 and is designated Class II. 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 perfo… The recall status is terminated (terminated April 23, 2021). Affected quantity: 470,954 rolls.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2020
- Initiation Date
- November 21, 2019
- Termination Date
- April 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 470,954 rolls
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.
Distribution Pattern
Nationwide, Canada, Germany, France, Switzerland, Denmark
Code Information
All lots