Tytek Medical recalls TPAK 14 gauge kits made before Oct 5, 2020 due to updated safety instructions for needle decompression procedures.
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Tytek Medical is recalling Tension Pneumothorax Access Kits (TPAK) made before October 5, 2020. The recall is for updated safety instructions to better explain risks of needle decompression procedures.
The recall involves updated instructions to clarify risks during needle decompression procedures. Proper placement is critical to avoid complications like air leaks or infections.
Healthcare professionals who use these kits for medical procedures are affected. Patients receiving treatment with these kits may be at risk if not properly instructed.
Check for model number TM-303 on the kit. Products were made before October 5, 2020 and sold under the brand Tytek Medical.
Look for model number TM-303 and production date before October 5, 2020 on the kit.
The recall involves updated safety instructions to better explain risks of needle decompression procedures.
Check if your kit has model number TM-303 and was made before October 5, 2020. If so, contact Tytek Medical for guidance.
The recall focuses on updated instructions for safer use, not an immediate risk of serious injury.
We’ve drafted a message you can send Tytek Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2610-2023 — Tytek Medical Tytek Medical Hello, I own a Tytek Medical that is covered by recall Z-2610-2023 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.
