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
I-flow recently determined that in a small quantity of on-q pumps with ondemand the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. in this condition the patient may receive continuous infusion at a rate greater than expected.
Model Catalog: CB003 (Lot serial: Products having a 10-digit); Model Catalog: CB006 (Lot serial: are NOT impacted by this); Model Catalog: CB003 (Lot serial: lot#s that is >0200521454); Model Catalog: CB006 (Lot serial: lot#s that is >0200521454); Model Catalog: CB003 (Lot serial: (ie. 0200521455 and greater)); Model Catalog: CB006 (Lot serial: Products having a 10-digit); Model Catalog: CB003 (Lot serial: recall.); Model Catalog: CB006 (Lot serial: recall.); Model Catalog: CB003 (Lot serial: are NOT impacted by this); Model Catalog: CB006 (Lot serial: (ie. 0200521455 and greater))