Health product recall

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 

  1. Covidien ChemoPlus Poly-coated Chemo Gown - Medium
  2. Covidien ChemoPlus Poly-coated Chemo Gown - Large
  3. Covidien ChemoPlus Poly-coated Chemo Gown - XL
  4. Covidien ChemoPlus Poly-coated Chemo Gown - XXL
  5. Covidien ChemoPlus Poly-coated Chemo Gown, Open Back ? Large
  6. Covidien ChemoPlus Poly-coated Chemo Gown, Open Back ? XLarge
  7. 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