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

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.
Devices & Diagnostics Letter