Galt Medical recalls Tearaway Introducers with specific catalog numbers and lots for potential bacterial endotoxins that could cause fever, chills, and low blood pressure.
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 models of Tearaway Introducers due to unsafe levels of bacterial endotoxins that may cause fever, chills, and low blood pressure. This risk affects patients using these medical devices, particularly those with compromised immune systems.
Bacterial endotoxins (pyrogens) in the product can trigger an inflammatory response, leading to fever, chills, and low blood pressure. These effects are more severe in individuals with compromised immune systems or medical conditions.
Patients using Tearaway Introducers for medical procedures are most at risk, especially those with weakened immune systems or existing health conditions.
Check the catalog number on the product (e.g., BNS-000-07, DIL-015-50) and the lot number (e.g., 18024880, 18043086) listed in the recall notice.
Identify the catalog number and lot number on your Tearaway Introducer to confirm if it is recalled.
The recalled models include catalog numbers BNS-000-07, BNS-000-10, DIL-015-50, DSS-005-11, DSS-005-12, DSS-006-045, DSS-007-05, DSS-007-165, DSS-010-03, DSS-010-04, DSS-010-045, DSS-010-05, DSS-012-07, SPT-003-46.
Bacterial endotoxins in the product may cause fever, chills, and low blood pressure, especially in patients with weakened immune systems.
The recall does not require immediate discontinuation; check the catalog and lot numbers to confirm if your product is affected.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2565-2018 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-2565-2018 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.
