CARDIOHELP Gas Bottle Holder HKH 8880 — Class II medical device recall Z-1642-2018
Terminated recall by Maquet Cardiopulmonary Ag, reported 2018-05-16. There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrat
| Recall number | Z-1642-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiopulmonary Ag, Rastatt, N/A, Germany |
| Recall initiated | 2018-04-04 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-03-29 |
| Countries outside the US | CH, DE, FR, TH |
| Reason classes | packaging, device malfunction |
| Model numbers | 70105.0901 |
Product
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
Reason for recall
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
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-1642-2018. 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.