Tytek Medical Inc: TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a te

Is my product affected?

TyTek Tension Pneumothorax Access Kit TPAK10: 10 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-310

• UPC 00855204008020

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

What happened

Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit TPAK10 (10 gauge, 3.25 inch), a medical device intended to remove air from the pleural cavity in patients with tension pneumothorax. The recall affects 4,400 units distributed across Ohio, South Carolina, Virginia, and several international locations including Australia, Denmark, Finland, Germany, Hong Kong, China, Israel, Spain, The Netherlands, Turkey, the United Arab Emirates, and the United Kingdom. The affected devices include all lots produced prior to October 5, 2020, identified by UDI 00855204008020.

The reason for the recall is that the instructions for use (IFU) were updated to identify risks associated with needle decompression and to improve the artwork showing the correct placement site location. The source document does not specify a remedy or recommended action for affected consumers.

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: 4400 units Lot/code info: UDI: 00855204008020 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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