Recall Z-0930-2020— Tytek Medical Inc
Class I · Terminated
Class I FDA medical device recall by Tytek Medical Inc, initiated 2019-11-15, terminated 2020-10-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: A defect involving an occluded needle was discovered during a training exercise..
- Recalling firm
- Tytek Medical Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-11-15
- Terminated
- 2020-10-01
- Firm location
- Blue Ash, OH, United States
Product description
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.
Reason for recall
A defect involving an occluded needle was discovered during a training exercise.
Data sourced from openFDA. This site is unofficial and independent of the FDA.