CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The...

FDA Device Recall #Z-1642-2018 — Class II — April 4, 2018

Recall Summary

Recall Number Z-1642-2018
Classification Class II — Moderate risk
Date Initiated April 4, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Maquet Cardiopulmonary Ag
Location Rastatt, N/A
Product Type Devices
Quantity 14 units (1 US, 13 International)

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.

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from Maquet Cardiopulmonary Ag

Recall # Classification Product Date
Z-1823-2025 Class II Cardiohelp System HKH 8820 Wall Holder. Mountin... Apr 30, 2025
Z-2160-2018 Class II Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L)... May 14, 2018
Z-2159-2018 Class II Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L)... May 14, 2018
Z-2161-2018 Class II Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L)... May 14, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.