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BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medicatio...

FDA Recall #Z-0923-2021 — Class II — December 9, 2020

Recall #Z-0923-2021 Date: December 9, 2020 Classification: Class II Status: Terminated

Product Description

BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204

Reason for Recall

BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications

Recalling Firm

Becton Dickinson & Company — Franklin Lakes, NJ

Classification

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

Product Type

Devices

Product Quantity

US: 16250 units

Distribution

Alabama, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia. Foreign: Australia, Canada, Belgium and Singapore

Code Information

All lots within expiration date UDI: (01)50382904042047

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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