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
- Non-Reinforced Surgical Gowns
- Fabric Reinforced Surgical Gowns
- 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