U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Needle, aspiration and injection, disposable - Product Code GAA
원인
Not compatible: the luer connector on the intraosseus needle provided does not fit securely on the luer connection of the iv extension set in the module.
조치
Vital Signs, Inc. issued an "Urgent Medical Device Correction" letter dated June 30, 2009 to all direct and indirect accounts by first class mail. Consignees were informed of the affected device, asked to complete a Confirmation form for return and to return unused product for replacement.
For further questions, contact Vital Signs, Inc. at 1-973-790-1330 extension 404.
Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
제품 설명
Broselow/Hinkle Pediatric Emergency System; || Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, || INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ. || The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes.