Isolation Gown & Kendall Gown (2021-01-11)
- Starting date:
- January 11, 2021
- Posting date:
- January 22, 2021
- 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-74825
Last updated:
2021-01-22
Affected Products
- Gown Isolation W/Ties Univ Ylw
- Gown Isolation W/Ties Xl Ylw
- Gown Isolation W/Ties Univ Blue
- Gown Isolation W/Ties Xl Blue
- Gown Kendall Blue RG
- Gown Kendall Blue L
- Gown Kendall Blue XXL
Reason
Cardinal Health has initiated a medical device recall for the Cardinal Health Branded Isolation Gowns and Lab Coats and Kendall Branded Gowns due to a failure by the contract manufacturer to maintain a proper quality management system.
Affected products
A. Gown Isolation W/Ties Univ Ylw
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
- A1100PG
- A2100PG
- NON24258
- NON24258N
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
B. Gown Isolation W/Ties Xl Ylw
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
A1101PG
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
C. Gown Isolation W/Ties Univ Blue
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
- A1200PG
- A2200PG
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
D. Gown Isolation W/Ties Xl Blue
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
A2201PG
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
E. Gown Kendall Blue RG
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
- XXCT5000
- ZCT5000
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
F. Gown Kendall Blue L
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
- CT5101JIT
- XXCT5100
- XXCT5101
- ZCT5100
- ZCT5101
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
G. Gown Kendall Blue XXL
Lot or serial number
Multiple lots, contact manufacturer
Model or catalog number
- XXCT5102
- ZCT5102
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES