FDA-Device2020-02-19Class I
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
Tytek Medical Inc
Hazard
A defect involving an occluded needle was discovered during a training exercise.
Sold states
US (nationwide), and countries of: Europe, Australia and Hong Kong.
Affected count
3,565 units
Manufactured in
4700 Ashwood Dr Ste 445, Blue Ash, OH, United States
Products
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief