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Recall Observatory FDA recall evidence

Device product

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

Z-0923-2021

December 09, 2020

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 86994
Status
Terminated
Classification
Class II
Quantity
US: 16250 units
Official record key
device-enforcement:Z-0923-2021

Official wording

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

Code information: All lots within expiration date UDI: (01)50382904042047

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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