Tytek Medical Recalls
4 recalls on record · February 19, 2020 to September 27, 2023 · Medical Devices
Recalls by year
20
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 27, 2023Medical DevicesFDA
Tytek Medical Inc recalls TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patien
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
September 27, 2023Medical DevicesFDA
Tytek Medical Inc recalls TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate
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
September 27, 2023Medical DevicesFDA
Tytek Medical Inc recalls TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate rem
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
February 19, 2020Medical DevicesFDA
Tytek Medical Inc recalls PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to fac
Hazard: A defect involving an occluded needle was discovered during a training exercise.