ZOLL — Class II medical device recall Z-0042-2022
Terminated recall by ZOLL Circulation, Inc., reported 2021-10-13, distributed nationwide. Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
| Recall number | Z-0042-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Circulation, Inc., San Jose, CA, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-10-06 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2024-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, HU, PT, SG, TH, TW |
| Quantity | 5,524 kits |
| Reason classes | labeling, packaging |
| NDC | 08700-0793-01 |
| Model numbers | 8700-0793-01 |
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 for recall
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0042-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.