TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions
Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a device used in emergency treatment of a life-threatening condition. Although no illnesses or injuries are reported in the source text, the device poses inherent risk of harm (improper needle placement or decompression-related complications) if used without adequate instructions. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The TyTek Tension Pneumothorax Access Kit (TPAK), Model TM-303, manufactured by Tytek Medical Inc., is a medical device designed to remove air from the pleural cavity in patients with a tension pneumothorax—a potentially life-threatening condition. Approximately 439,146 units are subject to this Class II recall.
The FDA is recalling this device because its instructions for use do not adequately identify the risks associated with needle decompression or provide sufficiently clear guidance on proper placement site location. The manufacturer has updated the instructions to better communicate these hazards and improve the visual representation of the correct needle insertion site.
The recalled units were distributed to medical facilities in Ohio, South Carolina, and Virginia, as well as internationally to Australia, Denmark, Finland, Germany, Hong Kong/China, Israel, Spain, the Netherlands, Turkey, the UAE, and the United Kingdom. All units produced prior to October 5, 2020 (UDI: 00855204008006) are included in the recall.
Healthcare providers should obtain and review the updated instructions from Tytek Medical Inc. to understand the potential complications associated with needle decompression and to ensure proper device placement and use.
The recalled product
- Product
- 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
- Manufacturer
- Tytek Medical Inc
- Category
- Medical Device
- Hazard
- improper-placement
- inadequate-instructions
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 00855204008006 All lots produced prior to Oct 5
- 2020
Distribution
Distributed in 3 states:
- OH
- SC
- VA
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