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
Tube, gastro-enterostomy - Product Code KGC
원인
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
조치
Customers were notified by letter and instructed to not use or further distribute any of the affected lot numbers. Customers were further instructed to return the recalled products to Bard Access Systems (BAS) through a return goods authorization number. Questions and requests for assistance should be directed to BAS Customer Service at 800-290-1689.
Worldwide Distribution -- US, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America.
제품 설명
Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284, Bard Access Systems, Inc., Salt Lake City, UT 84116 USA. || The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support.