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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
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Hospira is issuing this safety notification to provide clarification wording for the technical service manuals of the plum a+/a+3 infusion pumps. the label revision is a re-wording meant to provide further context around need to inspect the fluid shield and the regulator closer to compliment the warnings that are currently part of the technical service manual.
Model Catalog: 12391 (Lot serial: All serial numbers); Model Catalog: 20679 (Lot serial: All serial numbers); Model Catalog: 20792 (Lot serial: All serial numbers); Model Catalog: 12618 (Lot serial: All serial numbers); Model Catalog: 20678 (Lot serial: All serial numbers)