3M DuraPrep Surgical Solution Patient Preoperative Skin Preparation(2015-08-24)

Starting date:

August 24, 2015

Posting date:

September 24, 2015

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-55026

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  Reason
• 
  Affected products

Affected Products

A. 3M DuraPrep Surgical Solution Patient Preoperative Skin Preparation

Reason

During investigation into a complaint of discoloured Duraprep solution, 3m determined that the product solution had unintended exposure to the sterilant during package sterilization. This type of exposure would only be possible if the glass ampule holding the solution is compromised with a crack. Direct exposure to the sterilant causes a color change from dark brown to yellow/clear and renders the product unfit for use given formation of by-products with the potential for sensitization, irritation and acute dermal toxicity.

Affected products