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smiths medical portex Loss of Resistance Device, REF 100/398/000

FDA Recall #Z-0152-2022 — Class II — December 8, 2020

Recall #Z-0152-2022 Date: December 8, 2020 Classification: Class II Status: Terminated

Product Description

smiths medical portex Loss of Resistance Device, REF 100/398/000

Reason for Recall

The labeling was missing information on sterilization and prohibition of reuse.

Recalling Firm

Smiths Medical ASD Inc. — Minneapolis, MN

Classification

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

Product Type

Devices

Product Quantity

3420 devices

Distribution

Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates

Code Information

Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003

Status

Terminated

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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