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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-0361-2024 - Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include:
1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, ...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0362-2024 - Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P;
2. BreathTech Ch...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0363-2024 - Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 91...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0364-2024 - Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0369-2024 - Medline manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CP...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0366-2024 - Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. STAT-Check Adult Resuscitator REF #: SC9101B;
2. STAT-Check Infant Resus...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0367-2024 - Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP;
2. V-Car...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0368-2024 - Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF #...
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2
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11/21/2023
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SunMed Holdings, LLC
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Z-0365-2024 - Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include:
1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, S...
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2
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11/21/2023
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SunMed Holdings, LLC
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