Ventlab LLC: Medical Device Recall in 2014 - (Recall #: Z-1948-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.

Product Classification:

Class I

Date Initiated: May 16, 2014
Date Posted: July 9, 2014
Recall Number: Z-1948-2014
Event ID: 68242
Reason for Recall:

The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

Status: Terminated
Product Quantity: 251,384
Code Information:

Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102; Lot #200349. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000; Lot #s 107029 -107634. VN2002; Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.

Distribution Pattern:

US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,

Voluntary or Mandated:

Voluntary: Firm initiated