Z-0923-2021 Class II Terminated
FDA device recall Z-0923-2021 was initiated by Becton Dickinson & Company on December 9, 2020 and is designated Class II. 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 The recall status is terminated (terminated August 10, 2022). Affected quantity: US: 16250 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2021
- Initiation Date
- December 9, 2020
- Termination Date
- August 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 16250 units
Product Description
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
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
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
Code Information
All lots within expiration date UDI: (01)50382904042047