FDA Device recall Z-0046-2022
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STER…
- FDA Device
- Class II
- terminated
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STER… 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-0046-2022 |
| 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 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
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-0046-2022%22
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