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Tytek PneumoDart Recall / Class 1 FDA recall

To be clear, this was a voluntary recall initiated by TyTek Medical, following an occlusion issue that was identified during a training exercise. There have been no injuries or fatalities as a result of this issue.

Tytek Medical has issued a product recall on the affected batch Lot # 190524J69 with expiration date of 2026-05-24.  To determine whether you have any of the affected product, please check for the lot number and expiration date as shown below.

PneumoDart Recall Advice

 

All customers have been notified and received replacement products, however, if you have any of the affected product, do not use it, remove it from inventory immediately, contact us, and return it via UPS Account #R5513V or DHL Account #958855282 to: Tytek Medical, 4700 Ashwood Drive, Suite 445, Cincinnati, OH 45241 USA.

 

TyTek Medical has replaced the assembler responsible for this issue and instituted additional manufacturing and quality procedures. Each product is 100% tested for occlusions.  The PneumoDart is an effective tension pneumothorax needle, offering both convenience and safety. Despite this voluntary recall, we anticipate its continued safe use in the marketplace.

 

Please don’t hesitate to contact us at 1-513-872-7326 or email us at michelle@tytekgroup.com if you would like further information.