TyTek Tension Pneumothorax Access Kit Instructions Updated for Needle Decompression Safety
Tytek Medical is updating instructions and visual guidance for its tension pneumothorax kit to clarify needle decompression risks and proper placement. The update affects 4,400 units distributed in the US and international locations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II recall involves updating instructions for use and instructional artwork for a medical device. No illnesses, injuries, or adverse events have been reported. The update represents a compliance and communication improvement to better clarify procedural risks and placement guidance rather than a response to a documented product defect or harm.
Plain-English summary
Tytek Medical Inc is updating the instructions for use (IFU) and instructional artwork for its TyTek Tension Pneumothorax Access Kit (Model TM-310), a medical device intended to facilitate removal of air from the pleural cavity in patients with tension pneumothorax.
The FDA has classified this recall as a Class II action. The update involves revising the IFU to explicitly identify risks associated with needle decompression procedures and improving the artwork that depicts the proper placement site location for the needle.
The recall affects 4,400 units of the kit with UDI 00855204008020, produced prior to October 5, 2020. Distribution includes Ohio, South Carolina, and Virginia in the US, as well as Australia, Denmark, Finland, Germany, Hong Kong, China, Israel, Spain, the Netherlands, Turkey, the United Arab Emirates, and the United Kingdom.
The recalled product
- Product
- 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
- Manufacturer
- Tytek Medical Inc
- Affected units
- 4,400
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: 00855204008020 All lots produced prior to Oct 5
- 2020
Distribution
Part of a larger recall action
This product is one of 3 recalled by Tytek Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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