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
Contained within certain medical device kits manufactured by c.R. bard inc is a bard statlock stabilization device sub-assembly which includes a skin protectant prep pad component that is manufactured by aplicare inc. aplicare is changing its labeling to no longer identify the prep pad as sterile. however bard trays containing the prep pad indicate that components within the kit packaging are sterile. the recall will inform bard customers of the conflict between bard's and aplicare's labels. no product return is required.
Model Catalog: A902914 (Lot serial: ALL); Model Catalog: A902418 (Lot serial: ALL); Model Catalog: A902416 (Lot serial: ALL); Model Catalog: A800366 (Lot serial: ALL); Model Catalog: A800365 (Lot serial: ALL); Model Catalog: A800364 (Lot serial: ALL); Model Catalog: A902918 (Lot serial: ALL); Model Catalog: A902916 (Lot serial: ALL); Model Catalog: A902414 (Lot serial: ALL); Model Catalog: A119418M (Lot serial: ALL); Model Catalog: A119416M (Lot serial: ALL); Model Catalog: A897514 (Lot serial: ALL); Model Catalog: A897516 (Lot serial: ALL); Model Catalog: A897518 (Lot serial: ALL); Model Catalog: A303418A (Lot serial: ALL); Model Catalog: A303416A (Lot serial: ALL); Model Catalog: NG0100 (Lot serial: ALL); Model Catalog: A303414A (Lot serial: ALL); Model Catalog: 303118A (Lot serial: ALL); Model Catalog: 303116A (Lot serial: ALL); Model Catalog: 399100A (Lot serial: ALL); Model Catalog: 304100A (Lot serial: ALL); Model Catalog: A319518AM (Lot serial: ALL); Model Catalog: A319516AM (Lot serial: ALL); Model C
제품 설명
BARD URINE METER FOLEY TRAY;BARDEX LUBRICATH TEMPERATURE SENSING FOLEY TRAY W/BARD HYDROGEL;DRAINAGE BAG FOLEY TRAY W/ANTI-REFLUX CHAMBER;LUBRI-SIL COMPLETE CARE STATLOCK URINE METER FOLEY TRAY;STATLOCK NASOGASTRIC STABILIZATION DEVICE;INFECTION CONTROL A