Recall Z-1948-2014— Ventlab LLC
Class I · Terminated
Class I FDA medical device recall by Ventlab LLC, initiated 2014-05-16, terminated 2015-11-17. It names 3 FDA 510(k) clearances: K012842, K982215, K953546. Product: 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.. Reason: 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..
- Recalling firm
- Ventlab LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-05-16
- Terminated
- 2015-11-17
- Firm location
- Grand Rapids, MI, United States
510(k) clearances named in this recall
3 on FDA's record- K012842 — V*CARE MANUAL RESUSCITATOR
- K982215 — MANUAL RESUSCITATOR WITH ACE
- K953546 — MANUAL PULMONARY RESUSICITATOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.