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
Mask, oxygen - Product Code BYG
원인
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. the failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. while the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
조치
Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
제품 설명
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;