ZOLL — Class II medical device recall Z-0041-2022
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-0041-2022 |
|---|---|
| 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 | 4,812 kits |
| Reason classes | labeling, packaging |
| UPC / GTIN / UDI-DI | 00849111075190 |
| NDC | 08700-0781-01 |
| Model numbers | 8700-0781-01 |
Product
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
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-0041-2022. 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.