Galt Medical recalls Elite HV Hemostasis Valve Introducer Systems and related kits due to potential bacterial endotoxins that could cause fever, chills, and low blood pressure in patients.
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Galt Medical is recalling several Elite HV hemostasis valve introducer systems and kits because they might contain unsafe levels of bacterial endotoxins. This could lead to fever, chills, and low blood pressure in patients during medical procedures.
Bacterial endotoxins (pyrogens) can be introduced during manufacturing and may activate the body's inflammatory response. This can cause fever, chills, and low blood pressure in patients during medical procedures.
Healthcare professionals using these medical kits for procedures are most at risk. Patients receiving these kits during surgery or medical treatments may experience fever, chills, or low blood pressure.
Check for the product names: Elite HV Hemostasis Valve Introducer System, Elite HV Introducer Set, AngioGate HV Introducer Kit, or VSI Micro-HV Introducer Kit. Look for catalog numbers like BCL-100-04, BCL-100-05, CLI-105-14, KCL-102-05, etc.
Review the catalog numbers and lot numbers listed in the recall notice to confirm if your kit is affected.
The products might contain unsafe levels of bacterial endotoxins introduced during manufacturing, which can cause fever, chills, and low blood pressure in patients.
The recall notice does not specify a remedy, so check the product details to see if it is affected and contact the manufacturer for further instructions.
Yes, patients using these kits during medical procedures could experience fever, chills, or low blood pressure due to bacterial endotoxins.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2558-2018 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-2558-2018 from Galt 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.
