AVID Medical recalled 57 units of the Halyard ENT Pack on August 4, 2025. The recall stems from potential open header bag seals that may compromise sterility. Patients and healthcare providers must stop using this device immediately.
Potential for open header bag seals, compromising sterility.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AVID Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
The recalled product is the Halyard ENT Pack, Model Number: JACK421-04. It has a unique device identifier (UDI) of 10809160462973 and a lot number of 1647218. The expiration date for this product is July 17, 2027.
The recall indicates a potential for open header bag seals. This compromises the sterility of the medical device, posing a risk to patients.
There are no reported injuries or deaths associated with this recall. The hazard level is classified as high due to the potential risk of compromised sterility.
Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided by AVID Medical or contact their healthcare provider for further instructions.
Patients can reach AVID Medical, Inc. via email for more information and further instructions regarding the recall.
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