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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 21 Results
510(K) Number: K012842
 
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Product Description
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FDA Recall
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Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory confi... 2 11/21/2023 SunMed Holdings, LLC
Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configura... 2 11/21/2023 SunMed Holdings, LLC
Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configuratio... 2 11/21/2023 SunMed Holdings, LLC
Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurati... 2 11/21/2023 SunMed Holdings, LLC
Medline manual resuscitators with integrated manometer, multiple accessory configurations to include... 2 11/21/2023 SunMed Holdings, LLC
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configur... 2 11/21/2023 SunMed Holdings, LLC
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configuration... 2 11/21/2023 SunMed Holdings, LLC
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to includ... 2 11/21/2023 SunMed Holdings, LLC
Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurati... 2 11/21/2023 SunMed Holdings, LLC
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporati... 1 11/01/2012 Ventlab Corporation
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