Recall Z-1642-2018— Maquet Cardiopulmonary Ag
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiopulmonary Ag, initiated 2018-04-04, terminated 2019-03-29. It names one FDA 510(k) clearance: K102726. 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: There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations..
- Recalling firm
- Maquet Cardiopulmonary Ag
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-04
- Terminated
- 2019-03-29
- Firm location
- Rastatt, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.