Stradis Healthcare recalls Ablation Pack Item No. 682-130 due to potential sterility breaches from incomplete bag sealing. Affected units have specific serial numbers and UDI codes.
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 its Ablation Pack (Item No. 682-130) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the medical kit, posing a risk during surgical procedures.
The manufacturing process may leave the outer bag of the medical kit incompletely sealed. This could allow contamination, breaking the sterility required for surgical procedures and potentially causing infections.
Healthcare professionals using the Ablation Pack for medical procedures are most at risk. Patients undergoing surgery with this kit could face infection if sterility is compromised.
Check for the product name 'Ablation Pack', item number 682-130, and serial numbers starting with 22237491040. The UDI/DI codes are M7526821301 (case) and M7526821300 (kit).
Identify the product by checking the item number (682-130), serial numbers starting with 22237491040, and UDI/DI codes (M7526821301 for case, M7526821300 for kit).
The product is the Ablation Pack with item number 682-130.
Check for serial numbers starting with 22237491040 and UDI/DI codes M7526821301 (case) or M7526821300 (kit).
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-0539-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0539-2023 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.
