Recall Z-0923-2021
Becton Dickinson & Company · initiated December 9, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All lots within expiration date UDI: (01)50382904042047
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
FDA-determined cause: Labeling Change Control
Action taken
BD issued Urgent Medical Device notification on 12/9/20 to Distributors, Hospitals stating reason for recall, health risk and action to take: Immediately review your inventory for the specific Catalog numbers listed above. 2. As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this recall notification. Email an excel file listing of all customers to BDRC17@bd.com within 72 hours of receipt of this letter so that BD may initiate customer notification. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 4. A copy of the customer communication is attached for your reference. Customer/Technical Support (844) 823-5433 MonFri 8:30am and 5:00pm (EST) For customers outside the US, contact your local BD representative or distributor.
Details
- Recall number
- Z-0923-2021
- Initiated
- December 9, 2020
- Terminated
- August 10, 2022
- Quantity
- US: 16250 units
- 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
- Recalling firm
- Becton Dickinson & Company, Franklin Lakes, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0924-2021 Class II | BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of…BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated… | 12/09/2020Terminated |