Ventlab Corporation: Medical Device Recall in 2012 - (Recall #: Z-0170-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: July 11, 2012

Date Posted: November 7, 2012

Recall Number: Z-0170-2013

Event ID: 63347

Reason for Recall:

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

Status: Terminated

Product Quantity: 14,602 total for all units

Code Information:

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.

Distribution Pattern:

Nationwide Distribution including IL, OH, NY and TN.

Voluntary or Mandated:

Voluntary: Firm initiated