Health product recall

Gen Surg Laparoscopy Kit (2019-07-26)

Starting date:
July 26, 2019
Posting date:
August 9, 2019
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-70675



Last updated: 2019-08-09

Affected Products

A. Kit, Gen Surg Laparoscopy

B. Pack Urology Robotics

C. Pack Gyne Robotics

Reason

There is a risk of the filter housing separating prior to use in their MED-RX Insufflation Filters with Tubing. The Surgical kits from Cardinal Presource listed above each contain one of the affected CHS Insufflation Filters in their components.

Affected products

A. Kit, Gen Surg Laparoscopy

Lot or serial number

190921

Model or catalog number

PG30LGGTB

Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

UNITED STATES


B. Pack Urology Robotics

Lot or serial number

200663

Model or catalog number

SOT30RBOHD

Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

UNITED STATES


C. Pack Gyne Robotics

Lot or serial number

187172

Model or catalog number

SMA30RGOHC

Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

UNITED STATES