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U.S. Department of Health and Human Services

Class 2 Device Recall Gas Bottle Holder HKH 8880

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 Class 2 Device Recall Gas Bottle Holder HKH 8880see related information
Date Initiated by FirmApril 04, 2018
Create DateMay 04, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall NumberZ-1642-2018
Recall Event ID 79811
510(K)NumberK102726 
Product Classification Accessory equipment, cardiopulmonary bypass - Product Code KRI
ProductCARDIOHELP 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.
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
Recalling Firm/
Manufacturer		 Maquet Cardiopulmonary Ag
Kehler Strasse 31
Rastatt Germany
Manufacturer Reason
for Recall		There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
FDA Determined
Cause 2		Device Design
ActionThe 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 fieldactions@maquet.com or by faxing the form to +1 (973) 629-1655.
Quantity in Commerce14 units (1 US, 13 International)
DistributionThe product was distributed to the following US state: MO. The product was distributed to the following foreign countries: France, Germany, Switzerland, and Thailand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRI
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