Devices

Windstone Medical Recalls Surgical Kits

Windstone Medical Packaging has recalled (Class 1) its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assist’s 2023 ongoing recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. The recalled kits contain Nurse Assist Sterile Saline which could not be verified as having the required sterility assurance, a recall notice says. The recall doesn’t affect the integrity of the other kit components, it says.

Serious adverse health consequences are possible if affected kits are used, including blood stream infections, urinary tract infections that may turn into bladder problems and, if not treated, may develop into a more serious kidney condition (ascending pyelonephritis), ophthalmic (eye) infections, or respiratory infections such as pneumonia, according to the notice.

The company says the convenience kits are intended for use in general clinical procedures. The Local Lower Extremity Pack is designed to be used during procedures related to the lower limbs (fixing knee or hip joints, repairing blood vessels, and treating foot problems). The In-House Ocular Pack supports eye-related interventions, and the Closure Kit is designed to be used for wound closure and dressing following various clinical procedures.

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