FDA Device recall Z-0042-2022
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabil…
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabil… by Zoll Circulation, citing labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0042-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-06 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zoll Circulation |
| Distribution | US |
Product
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Reason
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0042-2022%22
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