Becton Dickinson & Company: 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 (reg

Is my product affected?

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

• UPC 50382904042047

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company recalled BD Stimex Insulated Needle 22G x 2.13in products used for administering medications for anesthesia or analgesia to specific anatomical locations. The recall was initiated because the European Notified Body, NSAI, advised that the instructions for use needed to be updated to include general contraindications. A total of 16,250 units were distributed in the United States across Alabama, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, and Virginia, as well as internationally in Australia, Canada, Belgium, and Singapore. All lots within the expiration date with the specified UDI are affected.

The source does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 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 Quantity: US: 16250 units Lot/code info: All lots within expiration date UDI: (01)50382904042047

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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