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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-1634-2023 - HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067840
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1635-2023 - BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass
Item no. 701067859
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1636-2023 - BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass
Item no. 701067905
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1637-2023 - QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 50000-USA 701067891
HMO 51000-USA 701067895
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1643-2023 - QUADROX-iR, used during cardiopulmonary bypass
Model Item No. Description
BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating
BE...
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1639-2023 - BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067829
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1640-2023 - QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 10000-USA 701070412
HMO 11000-USA 701070416
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1641-2023 - 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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05/26/2023
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Maquet Medical Systems USA
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Z-1642-2023 - Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA 701070445
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2
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05/26/2023
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Maquet Medical Systems USA
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Z-1638-2023 - QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 70000-USA 701067820
HMO 71000-USA 701067823
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2
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05/26/2023
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Maquet Medical Systems USA
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