Stradis Healthcare recalls Vein RF Pack (Item No. 682-1942NL1) due to potential sterility breaches from incomplete bag sealing. Affected units have specific UDI/DI and serial numbers.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling Vein RF Pack medical kits because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the kit, risking infection during medical procedures.
The outer bag may not seal properly during manufacturing, creating a path for contaminants to enter the sterile kit. This could lead to infections if the kit is used without proper sterility.
Healthcare professionals using the Vein RF Pack for medical procedures are most at risk. Patients receiving procedures with this kit could face infection if sterility is compromised.
Check for the item number 682-1942NL1 on the Vein RF Pack. Look for UDI/DI (case) M7526821942NL11 or UDI/DI (kit) M7526821942NL10. Serial numbers starting with 22251491808 indicate affected units.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your Vein RF Pack is affected.
The recall addresses a potential sterility breach risk, but the hazard is low risk as it does not cause immediate injury or death in normal use.
Check for the item number 682-1942NL1, UDI/DI (case) M7526821942NL11, UDI/DI (kit) M7526821942NL10, or serial numbers starting with 22251491808.
The recall record does not specify a remedy, so contact Stradis Healthcare directly for guidance.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0545-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0545-2023 from Stradis Healthcare. 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.
