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BD Regional Block Needles 22G x 1.50in (50 units/cs.).… recallZ-0924-2021 · Becton Dickinson & Company · initiated Dec 9, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Labeling Change Control

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-0924-2021
Status
Terminated
Initiated by the company
Dec 9, 2020
Recalling firm
Becton Dickinson & Company
Quantity
105880 units US
Product code
N/A
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

Product description

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

Code information (models, lots, serial numbers)

All lots within expiration date UDI: (01)50382904083484

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 86994).

Sources and updates

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