Reported Nov 7, 2012 · Terminated
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce…
Ventlab Corporation
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 Corporation · 155 Boyce Dr · Mocksville, NC · 27028-4187
Is this the product you have?
- Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use
- Manufactured byVentlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 Lot #100196, BT2216 2 Lot #100138, BT2216F 3 Lot #100139, BT2216K 4 Lot #100197, BT2220 5 Lot #100140, BT2220 6 Lot #100141, BT2416 7 Lot #100142, BT2416F 8 Lot #100143, BT2416K 9 Lot #100198, BT2420 10 Lot #100144, BT2420F 11 Lot #100145 and BT2420FK 12 Lot #101081. - Amount recalled
- 14,602 total for all units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
Stop using this product now
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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