SwiftSet Topical Skin Adhesive (2018-05-21)

Starting date:

May 21, 2018

Posting date:

April 4, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Microbial Hazard

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69472

Last updated: 2019-04-05

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  Reason
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  Affected products

Affected Products

SwiftSet Topical Skin Adhesive

Reason

Medtronic received notification from original equipment manufacturer: Advanced Medical Solutions (AMS) of a field action related to specific production lots of the SwiftSet product. AMS has received user complaints that the product has become solid and polymerizing before use. AMS's investigation confirms there is potentially a shortening of shelf life of the product. The adhesive may have prematurely started to or has completely polymerized within the ampoule rendering the adhesive too thick or completely solid, preventing the adhesive from being expressed from the device.

Affected products