CLASS I Device recall · Reported 9 Jul 2014 · FDA Enforcement Report
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000 recalled
Ventlab is recalling Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, distributed nationwide in the US. The recall was initiated on 16 May 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1948-2014
- FDA event ID
- 68242
- Recalling firm
- Ventlab, Grand Rapids, MI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 May 2014
- FDA classified
- 3 Jul 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 16 May 2014 | Recall initiated by company | |
| 3 Jul 2014 | Classified by FDA | +48 days |
| 9 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS I | Stat-Check Resuscitator, Adult Manual Emergency recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
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