CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Cardiohelp Gas Bottle Holder HKH 8880, Product recalled

Maquet Cardiopulmonary is recalling Cardiohelp Gas Bottle Holder HKH 8880, distributed in Missouri. The recall was initiated on 4 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUS: 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

Quantity recalled14 units (1 US, 13 International)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1642-2018
FDA event ID: 79811
Recalling firm: Maquet Cardiopulmonary, Rastatt, N/A
Classification: Class II
Status: Terminated
Recall initiated: 4 Apr 2018
FDA classified: 4 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

4 Apr 2018	Recall initiated by company
4 May 2018	Classified by FDA	+30 days
16 May 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was 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.

Missouri

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Maquet Cardiopulmonary

All 7

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6 Aug 2025Device	CLASS II	Sprinter Cart/Sprinter Cart XL Infusion Pole recalled	Maquet Cardiopulmonary	Device Malfunction	Nationwide
4 Jun 2025Device	CLASS II	Cardiohelp System HKH 8820 Wall Holder recalled	Maquet Cardiopulmonary	Device Malfunction	IL, MO
20 Jun 2018Device	CLASS II	Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag	Maquet Cardiopulmonary	Device Malfunction	PR, VA
20 Jun 2018Device	CLASS II	Aortic Arterial Cannula (O.D.) recalled by Maquet Cardiopulmonary Ag	Maquet Cardiopulmonary	Device Malfunction	PR, VA

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