Reported May 16, 2018 · Terminated

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

Maquet Cardiopulmonary Ag

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet Cardiopulmonary Ag · Kehler Strasse 31 · Rastatt, N/A · N/A

- CARDIOHELP Gas Bottle Holder HKH 8880
- Product Code/Part Number 70105.0901
Product UsageThe 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

Lot codes and dates: US98880-020
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
Amount recalled: 14 units (1 US, 13 International)

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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