Health product recall

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 

  1. Covidien ChemoPlus Chemo Spill Kit, Nonsterile
  2. Covidien ChemoBloc Preparation and Administration Kit
  3. Covidien ChemoPlus Drug Spill Kit, Hospital
  4. Covidien ChemoPlus Drug Spill Kit, Institutional
  5. 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

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