Galt Medical recalls multiple vascular dilator products that may contain unsafe bacterial endotoxins, which can cause fever, chills, and low blood pressure in patients. Affected items include specific catalog numbers and lots.
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 vascular dilator products that might contain unsafe levels of bacterial endotoxins. These endotoxins can cause fever, chills, and low blood pressure in patients during medical use.
The products may contain unsafe levels of bacterial endotoxins (pyrogens) introduced during manufacturing. These endotoxins can trigger an inflammatory response in patients, leading to fever, chills, and low blood pressure.
Healthcare professionals who use these products for medical procedures are most at risk. Patients receiving these products could experience fever, chills, or low blood pressure.
Check for catalog numbers listed in the recall: DIL-100-12, DIL-600-11, INT-028-14, INT-028-24, INT-029-05, INT-106-01, INT-106-14, KIT-010-14, KIT-027-04, KIT-042-11, KIT-042-12, KIT-900-13, KIT-900-14, KIT-900-17, KIT-900-29, KIT-901-02, KIT-900-88, KIT-045-05, KIT-045-15. Also check for specific lot numbers provided in the recall.
If you have any of the recalled products, stop using them right away to prevent potential health risks.
The recall includes vascular dilators, tearaway introducers, and micro-access kits with specific catalog numbers and lot numbers listed in the notice.
Products may contain bacterial endotoxins that can cause fever, chills, and low blood pressure in patients during medical procedures.
Check the catalog numbers and lot numbers provided in the recall notice, which include specific items like DIL-100-12, DIL-600-11, and various lot numbers.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2559-2018 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-2559-2018 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.
