FDA-Device2021-02-03Class II

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

Becton Dickinson & Company
Hazard

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

Sold states
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
Affected count
US: 16250 units
Manufactured in
1 Becton Dr, Franklin Lakes, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2021

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