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HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

FDA Recall #Z-0744-2024 — Class II — November 10, 2023

Recall #Z-0744-2024 Date: November 10, 2023 Classification: Class II Status: Ongoing

Product Description

HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP

Reason for Recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Recalling Firm

Smiths Medical Asd Inc — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

31,685 total

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Code Information

Lot Number: 4330826 4384397

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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