FDAFDA · Food and drugs·Recall number Z-0930-2020
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.
Published February 19, 2020 · Recall initiated: November 15, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A defect involving an occluded needle was discovered during a training exercise.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tytek Medical Inc
- Distributor
- US (nationwide), and countries of: Europe, Australia and Hong Kong.
- Lot
- NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.