Tytek Medical Inc: 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 tensio

Is my product affected?

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

• UPC 00855204008006

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 TPAK 14 gauge 3.25 inch, a medical device intended to remove air from the pleural cavity in patients with tension pneumothorax. The recall affects 439,146 units produced before October 5, 2020, distributed across Ohio, South Carolina, Virginia, and several international locations including Australia, Denmark, Finland, Germany, Hong Kong, Israel, Spain, the Netherlands, Turkey, the United Arab Emirates, and the United Kingdom.

The reason for the recall is to update the instructions for use to identify risks associated with needle decompression and to improve the artwork showing the correct placement site location. The product's UDI is 00855204008006, which can be used to identify affected units.

The source does not specify a remedy or what affected consumers should do.

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: 439146 units Lot/code info: UDI: 00855204008006 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.

Related recalls

• Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FL2020-10-05
• BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.2020-10-05
• 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-3102020-10-05
• 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-3172020-10-05
• Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the refere2020-10-08

All FDA (Device enforcement) recalls