Ventlab Corporation: Medical Device Recall in 2012 - (Recall #: Z-0172-2013)

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:

Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single 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-0172-2013

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: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193.

Distribution Pattern:

Nationwide Distribution including IL, OH, NY and TN.

Voluntary or Mandated:

Voluntary: Firm initiated