Tytek Medical Recalls PneumoDart Devices Due to Occluded Needle Defect
Tytek Medical Inc is recalling 3,565 PneumoDart devices because a defect involving an occluded needle was discovered during a training exercise.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A defect involving an occluded needle was discovered during a training exercise."
Plain-English summary
Tytek Medical Inc is recalling 3,565 units of the PneumoDart, 14 ga x 3.25in. (REF TM-317). This compact, sterile device is intended for introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
The recall was initiated after a defect involving an occluded needle was discovered during a training exercise. The affected units are identified by NSN 6515-01-655-9514, Lot number 190524J69, and have an expiration date of May 24, 2026.
The devices were distributed nationwide in the United States, as well as in Europe, Australia, and Hong Kong. Healthcare facilities and users should stop using the affected devices and contact Tytek Medical Inc for further instructions.
The recalled product
- 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.
- Manufacturer
- Tytek Medical Inc
- Affected units
- 3,565
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24
- 2026
Distribution
Distributed nationwide across the United States.
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