CLASS I Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device recalled
Tytek Medical is recalling PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device, distributed nationwide in the US. The recall was initiated on 15 Nov 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0930-2020
- FDA event ID
- 84296
- Recalling firm
- Tytek Medical, Blue Ash, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Nov 2019
- FDA classified
- 12 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 15 Nov 2019 | Recall initiated by company | |
| 12 Feb 2020 | Classified by FDA | +89 days |
| 19 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A defect involving an occluded needle was discovered during a training exercise.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US (nationwide), and countries of: Europe, Australia and Hong Kong.
Questions about this recall
Is PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device recalled?
Yes. Tytek Medical recalled PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device on 15 Nov 2019. The recall is Class I and its status is Terminated. Recall number Z-0930-2020.
Why was it recalled?
A defect involving an occluded needle was discovered during a training exercise.
Which lots are affected?
NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
Where was it sold?
US (nationwide), and countries of: Europe, Australia and Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tytek Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TyTek Tension Pneumothorax Access Kit TPAK10:- Intended recalled | Tytek Medical | Other | OH, SC, VA |
| Device | CLASS II | TyTek PneumoDart- Intended for introduction into the body recalled | Tytek Medical | Other | OH, SC, VA |
| Device | CLASS II | TyTek Tension Pneumothorax Access Kit TPAK- Intended recalled | Tytek Medical | Other | OH, SC, VA |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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