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