Recall Z-1642-2018 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
Maquet Cardiopulmonary Ag
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 t
| Date | Apr 4, 2018 |
| Status | Terminated |
| Reason | There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. |
| 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 REC |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |