Health product recall

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

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

C-Section Pack

Lot or serial number

760282
781753
796527
831355

Model or catalog number

SMA30CSTTD

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES