Galt Medical recalls specific Introducer Kit- Coaxial Dilator models due to potential open seal in sterile barrier packaging. Affected units may have compromised sterility.
Due to a potential open seal in the sterile barrier packaging.
Galt Medical is recalling certain Introducer Kit- Coaxial Dilator models because the sterile packaging might have an open seal. This could lead to contamination during medical procedures if the kit is used without proper sterility.
The sterile packaging might have an open seal, which could allow contamination during medical procedures. This risk is specific to the packaging integrity and not the product itself.
Healthcare professionals using these kits for vascular procedures are most at risk. Patients receiving these kits during medical treatments could be affected if the packaging is compromised.
Check for model numbers KIT-002-28, KIT-002-34, KIT-002-35, KIT-011-40, KIT-011-62, KIT-038-04, KIT-039-03, KIT-039-13, or KIT-081-02/PS2-38. The UDI-DI codes and lot numbers listed in the recall notice also identify affected units.
Identify your kit's model number and UDI-DI code to confirm if it's affected by this recall.
The recall is due to a potential open seal in the sterile barrier packaging, which could compromise sterility during medical procedures.
The recall notice does not specify a remedy, so check the product details to see if it's affected and contact the manufacturer for further guidance.
The potential open seal could lead to contamination, but the recall indicates a low risk as the hazard is specific to packaging integrity and not the product itself.
We’ve drafted a message you can send Galt Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1735-2025 — Galt Medical Galt Medical Hello, I own a Galt Medical that is covered by recall Z-1735-2025 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.
