Reported Feb 19, 2020 · Terminated
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to…
Tytek Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tytek Medical Inc · 4700 Ashwood Dr Ste 445 · Blue Ash, OH · 45241-2684
Is this the product you have?
- 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.
- Lot codes and dates
- NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
- Amount recalled
- 3,565 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
A defect involving an occluded needle was discovered during a training exercise.
Using this product could cause serious injury, illness or death — stop using it now.
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