Galt Medical recalls Elite HV Hemostasis Valve Introducer System (REF 612802, Model BCL-100-04) due to potential open seal in sterile packaging. This could compromise sterility during medical procedures.
Due to a potential open seal in the sterile barrier packaging .
Galt Medical is recalling its Elite HV Hemostasis Valve Introducer System (REF 612802, Model BCL-100-04) because the sterile packaging might have an open seal. This could lead to contamination during medical procedures if the device is used without proper sterility.
The sterile packaging might have an open seal, which could allow contamination during medical procedures. If the device is not properly sterilized, it could introduce infections into the patient's body.
Healthcare professionals who use this device for medical procedures are affected. Patients receiving procedures with this device may be at risk if the packaging is compromised.
Check for the product name 'Elite HV Hemostasis Valve Introducer System', reference number 612802, and model number BCL-100-04. This device was sold with lot number S25128171.
Inspect the sterile packaging for any signs of an open seal or damage.
The recall indicates a potential open seal in the sterile packaging, which could compromise sterility during medical procedures. Do not use the device until you confirm the packaging is intact.
Check the packaging for any signs of an open seal. If you find damage, do not use the device and contact your healthcare provider for guidance.
The recall does not mention a specific remedy. You should check the packaging integrity and consult your healthcare provider if you have concerns.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1733-2025 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-1733-2025 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.
