Solex 7 Intravascular Heat Exchange Catheter Kit
Brand(s)
Summary
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 |
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
ZOLL CIRCULATION, INC
2000 RINGWOOD AVENUE
SAN JOSE, California
UNITED STATES
95131
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