FDAnews Device Daily Bulletin

Warning Letter: Plastic Bag, Envelope May Not Suffice as Device Packaging

July 10, 2009
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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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