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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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QUADROX-iR, used during cardiopulmonary bypass
Model Item No. ...
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2
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05/26/2023
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Maquet Medical Systems USA
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QUADROX-iR, used during cardiopulmonary bypass
Model Item No. ...
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2
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05/30/2023
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Maquet Medical Systems USA
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MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Ca...
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2
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10/25/2013
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Maquet Medical Systems USA
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MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)
Product Usage: ...
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2
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04/18/2013
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Maquet Cardiovascular, LLC
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HLS/HIT Set Advanced with Bioline and/or Softline Coating Console
Product Usage:
HLS/HIT Set A...
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2
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05/28/2015
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Maquet Cardiovascular Us Sales, Llc
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HLS Set Advanced with BIOLINE Coating
Custom tubing packs for the oxygenator
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2
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04/12/2016
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Maquet Cardiovascular Us Sales, Llc
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Cardiohelp Emergency Drive, Part No. 70104.8002
Product Usage:
The Cardiohelp Emergency Drive is...
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1
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03/28/2019
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Maquet Cardiovascular Us Sales, Llc
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CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901
Product Usage:
The Ca...
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2
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05/04/2018
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Maquet Cardiopulmonary Ag
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Cardiohelp-I System
Product Usage: A blood oxygenation and carbon dioxide removal system used ...
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2
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11/13/2014
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Maquet Cardiovascular Us Sales, Llc
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