BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medication...
FDA Recall #Z-0924-2021 — Class II — December 9, 2020
Product Description
BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
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
105880 units US
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)50382904083484
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated