FDAFDA · Food and drugs·Recall number Z-1948-2014
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.
Published July 9, 2014 · Recall initiated: May 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventlab LLC
- Distributor
- US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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