PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 3, 2021 Initiated: December 9, 2020 #Z-0924-2021

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

Details

Units Affected
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
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Becton Dickinson & Company. Units affected: 105880 units US.
Why was this product recalled?
BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications
Which agency issued this recall?
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0924-2021.