Baylis Medical recalls TorFlex Transseptal Guiding Sheaths with specific model numbers due to potential packaging defects that could lead to infection if used in patients.
There is a remote potential for the sterile packaging of lots 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 TorFlex Transseptal Guiding Sheaths because their sterile packaging might be compromised during shipping. This could lead to infection if the sheath is used in a patient without identifying a packaging defect.
The sterile packaging of the sheaths could be damaged during shipping or handling. If a defect isn't noticed and the sheath is used in a patient, there's a remote chance of infection.
Healthcare professionals who use these sheaths for medical procedures are likely affected. Patients receiving procedures with the recalled sheaths face a remote risk of infection.
Check for model numbers like TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, or TF85-32-63-37. The sheaths were sold to healthcare providers for medical procedures.
Identify if your sheath has model numbers listed in the recall, such as TF8-32-63-45 or TF85-32-63-90.
The recall states a remote risk of infection, not serious injury. The hazard is not severe enough to require immediate action.
Look for model numbers like TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, or TF8-32-63-135 on the sheath packaging.
No, the recall does not require stopping use. The hazard is remote and only a risk if packaging is compromised and not identified.
We’ve drafted a message you can send Baylis Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2069-2020 — Baylis Medical Baylis Medical Hello, I own a Baylis Medical that is covered by recall Z-2069-2020 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.
