Z-1642-2018Class II

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

Name: Z-1642-2018 CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901
Creator: Maquet Cardiopulmonary Ag
Published: 2018-04-04
License: https://open.fda.gov/license/

MAQUET CARDIOPULMONARY GmbH / initiated 2018-04-04 / Terminated / root cause: design

FDA source

Maquet Cardiopulmonary Ag began a recall of 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... on 2018-04-04. FDA classified it as Class II and gives the reason as "There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1642-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-04
Posted: 2018-05-04
Terminated: 2019-03-29
Recalling firm: MAQUET CARDIOPULMONARY GmbH
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.
Product code: KRI Accessory Equipment, Cardiopulmonary Bypass
Reason for recall: There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
Root cause tag: design
FDA root cause: Device Design
Action: The Urgent Medical Device Recall Removal letter was distributed on 4/4/18. The letter instructed the customer to: Please examine your inventory for the affected 701050901 Gas Bottle Holder HKH 8880 and immediately remove it from use. Please contact your Getinge representative or call the Maquet/Getinge Customer Support at +1 (888) 627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to +1 (973) 629-1655.
Quantity in commerce: 14 units (1 US, 13 International)
Distribution: The product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1642-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1642-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code KRI

K102726Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2011-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)