Covidien ChemoPlus Poly-coated Chemo 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-74827
Last updated:
2021-01-22
Affected Products
- Covidien ChemoPlus Poly-coated Chemo Gown - Medium
- Covidien ChemoPlus Poly-coated Chemo Gown - Large
- Covidien ChemoPlus Poly-coated Chemo Gown - XL
- Covidien ChemoPlus Poly-coated Chemo Gown - XXL
- Covidien ChemoPlus Poly-coated Chemo Gown, Open Back ? Large
- Covidien ChemoPlus Poly-coated Chemo Gown, Open Back ? XLarge
- Covidien ChemoPlus Poly-coated Chemo Gown ? XXLarge
Reason
Cardinal Health has initiated a medical device recall for the Covidien Branded Gowns due to failure by the contract manufacturer to properly maintain an effective quality management system.
Affected products
A. Covidien ChemoPlus Poly-coated Chemo Gown - Medium
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- CT5502
- TYCT5502
- XXCT5502
- ZCT5502
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
B. Covidien ChemoPlus Poly-coated Chemo Gown - Large
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- CT5503
- TYCT5503
- XXCT5503
- ZCT5503
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
C. Covidien ChemoPlus Poly-coated Chemo Gown - XL
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- XXCT5504
- ZCT5504
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
D. Covidien ChemoPlus Poly-coated Chemo Gown - XXL
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- XXCT5505
- ZCT5505
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
E. Covidien ChemoPlus Poly-coated Chemo Gown, Open Back ? Large
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- TYDP5001G
- XXDP5001G
- ZDP5001G
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
F. Covidien ChemoPlus Poly-coated Chemo Gown, Open Back ? XLarge
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- XXDP5002G
- ZDP5002G
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
G. Covidien ChemoPlus Poly-coated Chemo Gown ? XXLarge
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- XXDP5004G
- ZDP5004G
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES