FDAFDA · Food and drugs·Recall number Z-2610-2023
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
Published September 27, 2023 · Recall initiated: October 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Tytek Medical Inc
- Distributor
- OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
- Lot
- UDI: 00855204008006 All lots produced prior to Oct 5, 2020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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