# FDA recall Z-1642-2018

> **Maquet Cardiopulmonary Ag** · Class II · device recall initiated 2018-04-04.

## 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.

## Distribution

The product was distributed to the following US state: MO.  The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.

## Key facts

- **Recall number:** Z-1642-2018
- **Recalling firm:** Maquet Cardiopulmonary Ag
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-04
- **Report date:** 2018-05-16
- **Termination date:** 2019-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rastatt, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1642-2018

## Citation

> AI Analytics. FDA recall Z-1642-2018. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1642-2018. Source: US FDA. Licensed CC0.

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