—#185002

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

FDA product code: N/A
Affected lot / code info: All lots within expiration date UDI: (01)50382904042047

Why it was 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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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

Timeline

Recall initiated: 2020-12-09
Terminated: 2022-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185002. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.