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
Oxygen cylinders - Product Code NFB
원인
Cylinder could lose oxygen at high pressure after the filling process.
조치
The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Model 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.