Tytek Medical Inc: 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

Is my product affected?

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

• UPC 00855204008167

Check against the official notice below — it lists the full affected range.

What happened

Tytek Medical Inc is recalling 22,026 units of its TyTek PneumoDart device, which is used to remove air from the chest cavity in patients with a collapsed lung. The device was distributed in Ohio, South Carolina, Virginia, and several countries including Australia, Denmark, Finland, Germany, Hong Kong, Israel, Spain, the Netherlands, Turkey, the United Arab Emirates, and the United Kingdom. The recall affects all lots produced before October 5, 2020, identified by UDI 00855204008167.

The company is updating the device's instructions for use to better identify risks associated with needle decompression and to improve the artwork that shows where the device should be placed on the body. The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

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 Distribution: OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK Quantity: 22,026 units Lot/code info: UDI: 00855204008167 All lots produced prior to Oct 5, 2020

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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