A. Covidien ChemoPlus Chemo Spill Kit, Nonsterile (2021-01-11) | Recall Monitor

A. Covidien ChemoPlus Chemo Spill Kit, Nonsterile (2021-01-11)
Health Products,
Jan 11th, 2021 @ 12:00 AM

Basic Details

Issue: Medical Devices
Category: Medical Device
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Alert type: Medical Device Recall
Hazard classification: Type II

Products

Lot or serial numberBrand nameCompaniesModel or catalog number
915019XD. Covidien ChemoPlus Drug Spill Kit, Institutional
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
TYDP5016K
923184XE. Covidien ChemoPlus Chemo Prep & Admin Kit
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
XXCT4025
911609XB. Covidien ChemoBloc Preparation and Administration Kit
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
XXDP5106K
915016XC. Covidien ChemoPlus Drug Spill Kit, Hospital
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
CT4004
Multiple lots, contact manufacturer.A. Covidien ChemoPlus Chemo Spill Kit, Nonsterile
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
TYBB6016K

Introduction

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.

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