Health product recall

Isolation Gown & Kendall 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-74825

Last updated:
2021-01-22

Affected Products 

  1. Gown Isolation W/Ties Univ Ylw
  2. Gown Isolation W/Ties Xl Ylw
  3. Gown Isolation W/Ties Univ Blue
  4. Gown Isolation W/Ties Xl Blue
  5. Gown Kendall Blue RG
  6. Gown Kendall Blue L
  7. Gown Kendall Blue XXL

Reason

Cardinal Health has initiated a medical device recall for the Cardinal Health Branded Isolation Gowns and Lab Coats and Kendall Branded Gowns due to a failure by the contract manufacturer to maintain a proper quality management system.

Affected products

A. Gown Isolation W/Ties Univ Ylw

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number
  • A1100PG
  • A2100PG
  • NON24258
  • NON24258N
Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

B. Gown Isolation W/Ties Xl Ylw

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number

A1101PG

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

C. Gown Isolation W/Ties Univ Blue

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number
  • A1200PG
  • A2200PG
Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

D. Gown Isolation W/Ties Xl Blue

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number

A2201PG

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

E. Gown Kendall Blue RG

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number
  • XXCT5000
  • ZCT5000
Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

F. Gown Kendall Blue L

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number
  • CT5101JIT
  • XXCT5100
  • XXCT5101
  • ZCT5100
  • ZCT5101
Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

G. Gown Kendall Blue XXL

Lot or serial number

Multiple lots, contact manufacturer

Model or catalog number
  • XXCT5102
  • ZCT5102
Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES