AVID Medical recalls Halyard LAVH PACK Model USAR053-11 with Clearify Visualization System (5303907) due to potential leakage after EO sterilization. Affected units have specific UDI/DI and lot numbers.
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
AVID Medical is recalling Halyard LAVH PACK Model USAR053-11 with Clearify Visualization System (5303907) because a kit component may leak after EO sterilization. This could cause issues with the medical device's function or safety.
The kit component was sterilized using EO (ethylene oxide) instead of the manufacturer's recommended method, which may cause it to leak. This leakage could disrupt the device's operation or safety features.
Healthcare professionals using the Halyard LAVH PACK for medical procedures are likely affected. Patients using this device may be at risk if the kit component leaks.
Check for the model number USAR053-11 and catalog number 5303907 on the Halyard LAVH PACK. Affected units have UDI/DI 10809160372357 and lot number 1669869.
Identify the model number USAR053-11 and catalog number 5303907 on the Halyard LAVH PACK.
The kit component was subjected to EO sterilization, contrary to manufacturer recommendations, which may have led to the component leaking in the kit.
Check the product details to see if it matches the recalled model and catalog numbers. If it does, contact AVID Medical for further instructions.
The recall states the component may leak, but no specific risk of serious injury is mentioned. The danger level is low risk.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2964-2026 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-2964-2026 from AVID 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.
