Health product recall

Solex 7 Intravascular Heat Exchange Catheter Kit

Last updated

Summary

Product
Solex 7 Intravascular Heat Exchange Catheter Kit
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Affected products

Product Trade name

Lot or serial number

Model or catalog number

A. QUATTRO INTRAVASCULAR HEAT EXCHANGE CATHETER KIT

More than 10 numbers, contact manufacturer.

8700-0783-40

B. COOL LINE INTRAVASCULAR HEAT EXCHANGE CATHETER KI

More than 10 numbers, contact manufacturer.

8700-0781-40

C. ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT

More than 10 numbers, contact manufacturer.

8700-0782-40

D. SOLEX 7 INTRAVASCULAR HEAT EXCHANGE CATHETER KIT

142959
149990
151835
88835
89577
90334

8700-0793-40 (SL-2593AE)

Issue

This labeling correction involves revising the catheter IFU to include warning/caution statements about potential health risks due to overloading of the Sterile Saline fluid. This recall only affects the IFU; not the Catheters.

 

Initial recall date: 2021-09-30

Additional information

Details
Original published date: 2021-11-03
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

ZOLL CIRCULATION, INC
2000 RINGWOOD AVENUE
SAN JOSE, California
UNITED STATES

95131

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63524