3M Durapore Advanced Surgical Tape (2019-11-24)

Starting date:

November 24, 2019

Posting date:

December 20, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71931

Last updated: 2019-12-20

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  Reason
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  Affected products

Affected Products

3M Durapore Advanced Surgical Tape

Reason

3M Durapore Advanced Surgical Tape is being recalled due to unanticipated product performance in clinical settings with high humidity conditions and/or when the tape is exposed to normal and/or excessive amounts of oral secretions.  This use environment may cause tape bond failure, leading the tape to not perform as intended.  Further, the tape fibers may fray, enabling the fibers to be accidentally ingested or aspirated.  While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape in high moisture clinical applications has not fully met all of 3M's performance expectations.

Affected products