Tytek Medical recalls PneumoDart 14-gauge needles due to a defect that may cause occlusion during use. Affected units were sold with specific lot numbers and expiration dates.
A defect involving an occluded needle was discovered during a training exercise.
Tytek Medical is recalling PneumoDart 14-gauge needles because a defect could cause the needle to become occluded during use. This risk may affect medical procedures involving air removal from the pleural cavity.
The defect involves an occluded needle, which means the needle could block during use. This could prevent proper air removal from the pleural cavity, potentially causing complications in treating tension pneumothorax.
Healthcare professionals using PneumoDart needles for tension pneumothorax treatment are most at risk. Patients receiving this device during medical procedures may also be affected.
Check for the product name 'PneumoDart', 14-gauge size, and lot number 190524J69. The expiration date is May 24, 2026.
Verify the lot number and expiration date on the device packaging.
The defect involves an occluded needle, which may block during use.
Check for lot number 190524J69 and expiration date May 24, 2026 on the packaging.
The recall record does not specify a remedy, so contact Tytek Medical for further instructions.
We’ve drafted a message you can send Tytek Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0930-2020 — Tytek Medical Tytek Medical Hello, I own a Tytek Medical that is covered by recall Z-0930-2020 from Tytek Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
