Health product recall

Non-Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns & Royalsilk Non-Reinforced Surgical Gowns (2020-01-21)

Starting date:
January 21, 2020
Posting date:
January 31, 2020
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-72239

Last updated: 2020-01-31

Affected Products

  1. Non-Reinforced Surgical Gowns
  2. Fabric Reinforced Surgical Gowns
  3. Royalsilk Non-Reinforced Surgical Gowns

Reason

Cardinal Health is conducting this recall because the affected gowns were manufactured at locations that did not maintain proper environmental conditions as required by law, were not qualified by Cardinal Health and commingled with properly manufactured gowns. Cardinal Health cannot provide assurances that the identified item codes and lot numbers were properly sterilized. An improperly sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.

Affected products

A. Non-Reinforced Surgical Gowns

Lot or serial number

All in the XXXXJXXX format.

Model or catalog number
  • 9545, A9545
  • 9575, A9575
  • 9575EL, A9575EL
  • 9585
  • 9599
  • 95995, A95995
Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

Illinois

UNITED STATES

B. Fabric Reinforced Surgical Gowns

Lot or serial number

All in the XXXXJXXX format.

Model or catalog number
  • 9511, A9511
  • 9541, A9541
Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

Illinois

UNITED STATES

C. Royalsilk Non-Reinforced Surgical Gowns

Lot or serial number

All in the XXXXJXXX format.

Model or catalog number

9515, A9515

Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

Illinois

UNITED STATES