Cardinal Healths' Sterile Obstetrical Pack, Pack Prostate Rad and Pack Uteroscopy (2018-04-24)
- Starting date:
- April 24, 2018
- Posting date:
- May 18, 2018
- 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-66800
Affected products
A. Sterile Obstetrical Pack
B. Pack Prostate Rad
C. Pack Uteroscopy
Reason
Recall was initiated due to the expiry of a component used in the manufacturing of Cardinal Health Presource Kits. All other components contained within the kits are still within valid expiry. The expired lots of the indicated kits are to be reworked with a warning label indicating which component has expired and instructing the physician to dispose of the component at time of use, replacing it with non-expired stock from their inventory. The label will also indicate what the updated expiry of the kit is, advanced to the next component expiry date.
Affected products
A. Sterile Obstetrical Pack
Lot or serial number
670921
Model or catalog number
SMA30CSLG8
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
B. Pack Prostate Rad
Lot or serial number
738744
Model or catalog number
SOT30PRALJ
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
C. Pack Uteroscopy
Lot or serial number
564798
Model or catalog number
SOT30UPCCB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES