Recall Z-0170-2013
Ventlab Corporation · initiated July 11, 2012
Class I – dangerous or defective products that could cause serious health problems or death
Product
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. 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.
Codes / lots: Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253.
Reason for recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
FDA-determined cause: Component design/selection
Action taken
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
Details
- Recall number
- Z-0170-2013
- Initiated
- July 11, 2012
- Posted by FDA
- November 1, 2012
- Terminated
- June 30, 2013
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Quantity
- 14,602 total for all units
- Distribution
- Nationwide Distribution including IL, OH, NY and TN.
- Recalling firm
- Ventlab Corporation, Mocksville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0171-2013 Class I | Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0172-2013 Class I | Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0173-2013 Class I | V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by:…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0174-2013 Class I | Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by:…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0175-2013 Class I | AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by:…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0176-2013 Class I | Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0177-2013 Class I | Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0178-2013 Class I | Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0179-2013 Class I | Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0180-2013 Class I | AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |
| Z-0181-2013 Class I | AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab…Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 07/11/2012Terminated |