CLASS II Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
TyTek Tension Pneumothorax Access Kit TPAK- Intended recalled
Tytek Medical is recalling TyTek Tension Pneumothorax Access Kit TPAK- Intended for introduction into the body to, distributed in Ohio, South Carolina, Virginia. The recall was initiated on 5 Oct 2020 and the FDA has classified it as Class II.
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-2610-2023
- FDA event ID
- 92899
- Recalling firm
- Tytek Medical, West Chester, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2020
- FDA classified
- 19 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Oct 2020 | Recall initiated by company | |
| 19 Sep 2023 | Classified by FDA | +1079 days |
| 27 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Product as listed by the FDA
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
Where it was distributed
OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Questions about this recall
Is TyTek Tension Pneumothorax Access Kit TPAK- Intended for introduction into the body to recalled?
Yes. Tytek Medical recalled TyTek Tension Pneumothorax Access Kit TPAK- Intended for introduction into the body to on 5 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-2610-2023.
Why was it recalled?
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Which lots are affected?
UDI: 00855204008006 All lots produced prior to Oct 5, 2020
Where was it sold?
OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 I | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device recalled | Tytek Medical | Sterility | Nationwide |
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