Galt Medical recalls specific sterile surgical kits that may contain unsafe bacterial endotoxins, risking fever and chills in patients. Affected kits include TVS LPA and Enhance models with listed catalog numbers.
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 certain sterile surgical kits that may contain unsafe levels of bacterial endotoxins. These endotoxins can cause fever, chills, and low blood pressure in patients during medical procedures.
Bacterial endotoxins (pyrogens) in the kits can trigger an inflammatory response in patients, leading to fever, chills, and low blood pressure. This occurs because the endotoxins were introduced during manufacturing and may not be fully removed.
Patients receiving these surgical kits during medical procedures are at risk. Healthcare providers using the recalled kits for sterile applications may also be affected.
Check for catalog numbers KIT-071-01, KIT-071-03, KIT-071-10, KIT-071-11 for TVS LPA kits or KIT-075-02, KIT-075-03 with specific lot numbers for Enhance kits.
Identify if your kit has catalog numbers KIT-071-01, KIT-071-03, KIT-071-10, KIT-071-11 or KIT-075-02, KIT-075-03 with listed lot numbers.
The products may contain unsafe levels of bacterial endotoxins introduced during manufacturing, which can cause fever, chills, and low blood pressure in patients.
The recall record does not specify a remedy, so contact Galt Medical directly to determine next steps.
Yes, patients receiving these kits during medical procedures may experience fever, chills, and 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-2561-2018 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-2561-2018 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.
