Maquet Cardiopulmonary Ag recalls CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or…

Recall date

April 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1642-2018

FDA classification

Class II

Brand / firm

Maquet Cardiopulmonary Ag

Sold / distributed

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

Why it was recalled

There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.