Reported Jul 9, 2014 · Terminated

Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700,…

Ventlab LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ventlab LLC · 2710 Northridge Dr Nw · Grand Rapids, MI · 49544-9112

Is this the product you have?

  • Manual Resuscitator Bag SeriesAF1000, 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
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
1Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102
2Lot #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
3Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.
Amount recalled
251,384

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 17, 2015 · Data as of Sep 19, 5:26 PM UTC

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