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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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Z-1655-2023 - QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1656-2023 - QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMOD 70000-USA 701067840
BEQ-HMOD70000-USA 701067859
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1657-2023 - QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass
Model Item no.
BEQ-HMO 50000-USA 701067905
HMO 50000-USA 701067891
HMO 51000-USA ...
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1662-2023 - QUADROX-iR, used during cardiopulmonary bypass
Model Item No. Description
BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOL...
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1659-2023 - QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 70000-USA 701067820
HMO 71000-USA 7010678...
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1660-2023 - QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 10000-USA 701070412
HMO 11000-USA 701...
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1661-2023 - Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA ...
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2
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05/30/2023
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Maquet Medical Systems USA
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Z-1658-2023 - QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
BEQ-HMOD30000-USA 701070397
BEQ-HMOD30000-USA 701050330 ...
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2
|
05/30/2023
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Maquet Medical Systems USA
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