Becton Dickinson & Company: BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (regi

Is my product affected?

BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348

• UPC 50382904083484

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

What happened

Becton Dickinson & Company is recalling BD Regional Block Needles 22G x 1.50in (50 units per case), which are used to administer medications for anesthesia or pain relief to specific body areas. The recall was initiated because the European Notified Body, NSAI, advised that the instructions for use need to be updated to include general contraindications. The affected product was distributed in 18 U.S. states (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 Australia, Canada, Belgium, and Singapore. A total of 105,880 units in the U.S. are affected, encompassing all lots within the product's expiration date.

The record does not specify what remedy consumers or healthcare providers should undertake 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: 105880 units US Lot/code info: All lots within expiration date UDI: (01)50382904083484

Source

Official record: FDA (Device enforcement) ↗

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

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