Recall Z-0176-2013— Ventlab Corporation
Class I · Terminated
Class I FDA medical device recall by Ventlab Corporation, initiated 2012-07-11, terminated 2013-06-30. It names one FDA 510(k) clearance: K012842. Product: 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: Possible volume leakage through the inlet valve during compressions of the resuscitator bag..
- Recalling firm
- Ventlab Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-07-11
- Terminated
- 2013-06-30
- Firm location
- Mocksville, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.