C-Section Pack (2018-08-06)

Starting date:

August 6, 2018

Posting date:

October 19, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67904

• 
  Reason
• 
  Affected products

Affected products

C-Section Pack

Reason

Cardinal health packs contain the lots of smtihs pro-vent Arterial Blood Sampling (ABS) kits 4660p-1. These components contain Medline PVP-1 Prep Pad products that did not meet the specification for % Povidone Iodine at the 30 month time point (the product is currently labeled with a 36 month shelf life).

Affected products