FDA Enforcement
Class I
Terminated
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.
Recall: Z-0176-2013
·
Reported November 7, 2012
Enforcement
- Recall Number
- Z-0176-2013
- Event ID
- 63347
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ventlab Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 7, 2012
- Initiation Date
- July 11, 2012
- Classification Date
- November 1, 2012
- Termination Date
- June 30, 2013
- Address
- 155 Boyce Dr, N/A, Mocksville, NC, 27028-4187, United States
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
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Code Info
Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657.
Distribution
Nationwide Distribution including IL, OH, NY and TN.
Quantity
14,602 total for all units