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FDAnews Device Daily Bulletin
Warning Letter: Plastic Bag, Envelope May Not Suffice as Device Packaging
July 10, 2009
Ffrench Emergency Pocket Airway did not ensure that distributing devices in plastic bags packed in padded envelopes is enough to protect them from alteration or damage, according to a recent FDA warning letter
. The company manufactures the LifeStat Emergency Airway, a portable device for emergency cricothyrotomy that can be secured to a keychain.
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