Baylis Medical recalls NRG RF Transseptal Kits with specific model numbers due to a remote risk of packaging defects causing infection during medical use. Affected units include NTK-710-8545 and other variants.
There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
Baylis Medical is recalling certain NRG RF Transseptal Kits because their sterile packaging might be compromised during shipping, which could lead to infection if used in patients. This is a remote risk, meaning it's unlikely but important for medical safety.
The sterile packaging of the transseptal guiding sheath might get damaged during shipping or handling. If the packaging isn't checked and the kit is used in a patient, there's a small chance of infection due to contamination.
Healthcare professionals using the recalled kits for medical procedures are most at risk if the packaging is defective. Patients receiving these kits during procedures could face infection.
Check for model numbers like NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, and other variants listed in the recall notice. The kits were sold with specific lot numbers and model suffixes (S, N).
Look for model numbers such as NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, and other variants listed in the recall notice.
There is a remote risk of infection if the sterile packaging is compromised during shipping or handling and the product is used in a patient.
Check the model number on the kit. Affected models include NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, and other variants with suffixes like S or N.
The recall does not require stopping use immediately; however, if you have the affected model, you should check for packaging defects before use.
We’ve drafted a message you can send Baylis Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2070-2020 — Baylis Medical Baylis Medical Hello, I own a Baylis Medical that is covered by recall Z-2070-2020 from Baylis 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.
