High FDA (Devices)·Z-1642-2018·Announced 2018-05-16

Maquet Cardiohelp Gas Bottle Holder Recalled for Potential Clamp Failure

Maquet Cardiopulmonary Ag is recalling 14 units of the Cardiohelp Gas Bottle Holder HKH 8880 because the clamps may crack or break during strong vibrations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for patient transport where a structural failure could lead to harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Maquet Cardiopulmonary Ag is recalling 14 units of the CARDIOHELP Gas Bottle Holder HKH 8880 (Product Code/Part Number 70105.0901). This accessory is required for inter-hospital patient transport in aircraft and road vehicles, such as mobile intensive care units and ambulances, where it serves to hold an oxygen cylinder.

The recall was initiated because there is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. The product was distributed to one unit in the United States (Missouri) and 13 units in France, Germany, Switzerland, and Thailand.

Users should stop using the affected gas bottle holders and contact Maquet Cardiopulmonary Ag for further instructions. The recall is classified as Class II by the FDA.

The recalled product

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
Manufacturer: Maquet Cardiopulmonary Ag
Category: Medical Device — Patient Transport Equipment
Hazard: structural-failure
falling-object

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

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

Distribution

Distributed in 1 state:

Same manufacturer · Maquet Cardiopulmonary Ag

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