medical Class II Updated 2023-09-27

Tytek Medical Inc recalls TyTek PneumoDart- Intended for introduction into the body to

Recalled Product

TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317

Hazard / Issue

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

Issued by

FDA

Affected States: OH, SC, VA
Lot/Code Info: UDI: 00855204008167 All lots produced prior to Oct 5, 2020
View official government recall

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