A. Covidien ChemoPlus Chemo Spill Kit, Nonsterile (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-74829
Last updated:
2021-01-22
Affected Products
- Covidien ChemoPlus Chemo Spill Kit, Nonsterile
- Covidien ChemoBloc Preparation and Administration Kit
- Covidien ChemoPlus Drug Spill Kit, Hospital
- Covidien ChemoPlus Drug Spill Kit, Institutional
- Covidien ChemoPlus Chemo Prep & Admin Kit
Reason
Cardinal Health has initiated a field safety correction notice for Covidien Branded Gowns due to failure by the contract manufacturer to properly maintain an effective quality management system. The affected product is a component within the Covidien Chemoplus and Chemobloc Chemo Spill and Preparation/Administration Kits.
Affected products
A. Covidien ChemoPlus Chemo Spill Kit, Nonsterile
Lot or serial number
Multiple lots, contact manufacturer.
Model or catalog number
- TYBB6016K
- TYDP5108K
- XXBB6016K
- XXDP5108K
- ZBB6016K
- ZDP5108K
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
B. Covidien ChemoBloc Preparation and Administration Kit
Lot or serial number
911609X
Model or catalog number
- XXDP5106K
- ZDP5106K
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
C. Covidien ChemoPlus Drug Spill Kit, Hospital
Lot or serial number
- 915016X
- 915018X
Model or catalog number
- CT4004
- CT4004CHM
- TYCT4004
- XXCT4004
- ZCT4004
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
D. Covidien ChemoPlus Drug Spill Kit, Institutional
Lot or serial number
- 915019X
- 915020X
- 915021X
- 915022X
- 924422X
- 925174X
Model or catalog number
- TYDP5016K
- XXDP5016K
- ZDP5016K
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
E. Covidien ChemoPlus Chemo Prep & Admin Kit
Lot or serial number
923184X
Model or catalog number
- XXCT4025
- ZCT4025
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES