Galt Medical recalls Elite HV Introducers with specific catalog numbers 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 specific Elite HV Introducer models because they may contain unsafe levels of bacterial endotoxins. This could lead to fever, chills, and low blood pressure in patients during medical use.
Bacterial endotoxins (pyrogens) in the product can trigger an inflammatory response in patients, causing fever, chills, and low blood pressure. This occurs during medical procedures when the device is used.
Patients using these medical devices for procedures may be affected. Healthcare providers who use the recalled models are most at risk.
Check for catalog numbers CLI-200-26, CLI-210-16, CLI-212-07, or KCL-212-055 on the Elite HV Introducer. The lot numbers listed in the recall notice also identify affected units.
Identify the catalog number and lot number on the Elite HV Introducer to confirm if it is recalled.
The recalled catalog numbers are CLI-200-26, CLI-210-16, CLI-212-07, and KCL-212-055.
Affected lot numbers include 18032057, 18032058, 18001013, 18046016, 18162838, and others listed in the recall notice.
Using these products may cause fever, chills, and low blood pressure in patients 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-2562-2018 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-2562-2018 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.
