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