medical Class II Updated 2018-05-16

Maquet Cardiopulmonary Ag recalls CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Num

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Affected States: MO

Lot/Code Info: US: 98880-020 Foreign: 98880 - 002, 98880 - 004, 98880 - 005, 98880 - 006, 98880-009, 98880-010, 98880-011, 98880-012, 98880- 013, 98880-014, 98880-016, 98880-017, 98880-018

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