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Maquet Cardiopulmonary Ag recalls CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle
Recalled May 16, 2018 · FDA recall Z-1642-2018 · Maquet Cardiopulmonary Ag
Hazard
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. · FDA Class II
Units
14 units (1 US, 13 International)
Sold at
The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
Description
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
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.
Manufacturer(s)
Maquet Cardiopulmonary Ag
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →