Home / Recalls / Ventlab Corporation / Z-0176-2013

Z-0176-2013 Class I Terminated

Recalled by Ventlab Corporation — Mocksville, NC

Recall Details

Product Type
Devices
Report Date
November 7, 2012
Initiation Date
July 11, 2012
Termination Date
June 30, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,602 total for all units

Product Description

Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Reason for Recall

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Distribution Pattern

Nationwide Distribution including IL, OH, NY and TN.

Code Information

Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657.

Other recalls by Ventlab Corporation

  • Z-0171-2013 Class I — Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Res (July 11, 2012)
  • Z-0181-2013 Class I — AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: V (July 11, 2012)
  • Z-0180-2013 Class I — AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventla (July 11, 2012)
  • Z-0170-2013 Class I — Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured b (July 11, 2012)
  • Z-0179-2013 Class I — Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 15 (July 11, 2012)
  • Z-0178-2013 Class I — Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, (July 11, 2012)
  • Z-0173-2013 Class I — V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufacture (July 11, 2012)
  • Z-0174-2013 Class I — Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactu (July 11, 2012)
  • Z-0175-2013 Class I — AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufacture (July 11, 2012)
  • Z-0172-2013 Class I — Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-C (July 11, 2012)