Health product recall

Cardinal health - surgical gowns products

Last updated

Summary

Product
Cardinal health - surgical gowns products
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information

Affected products

Affected Products

Lot or serial number

Model or catalog number

SMARTGOWN™ BREATHABLE SURGICAL GOWNS WITH RAGLAN SLEEVES

More than 10 numbers, contact manufacturer.

32474
A32474
A9041EL
C32474

SMARTSLEEVE™ POLY-REINFORCED BREATHABLE SLEEVE SURGICAL GOWNS

More than 10 numbers, contact manufacturer.

9011
A9011

CARDINAL HEALTH™ POLY-REINFORCED SURGICAL GOWNS

21CKQ001
21CKQ002
21HKQ001

A9070
A9070N

ROYALSILK® NON-REINFORCED SURGICAL GOWNS

More than 10 numbers, contact manufacturer.

A9518
A9548
A9578
A95998

Issue

Cardinal health is conducting this recall due to the potential for open packaging seals for sterile surgical gowns. The investigation isolated the issue to gowns manufactured on a singular packaging line. The recall is being initiated on November 12, 2021.

Recall start date: 2021-11-03

Additional information

Details
Original published date: 2021-11-19
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies

CARDINAL HEALTH CANADA INC.

1330 MEYERSIDE DRIVE, MISSISSAUGA

ON, CANADA

L5T 1C2

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63617