Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Icu medical inc. has identified a potential leak with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or potentially introduce a small amounts of air into the line.
Model Catalog: 42587-05 (Lot serial: 3247898); Model Catalog: 42590-05 (Lot serial: 3247898); Model Catalog: 42587-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3292882); Model Catalog: 42587-05 (Lot serial: 3292882); Model Catalog: 011-46104-41 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42583-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42584-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42585-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 011-46101-92 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42582-06 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3257008); Model Catalog: 42582-06 (Lot serial: 3257008); Model Catalog: 46107-53 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3264105); Model Catalog: 42594-05 (Lot serial: 3265442); Model Catalog: 42582-06 (Lot serial: 3264105); Model Catalog: 42641-06 (Lot serial: 3249806)
제품 설명
TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH;TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH 3 ML SQUEEZE FLUSH DEVICE;TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS;TRANSPAC IV MONITORING KIT W/4 WAY STOPCOCK 3 WAY STOPCOCK AND