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                Recalls, Market Withdrawals, & Safety Alerts

Recalls, Market Withdrawals, & Safety Alerts

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          Recalls, Market Withdrawals, & Safety Alerts
          BD Announces Voluntary Recall on Intraosseous ProductsRecalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT
    
  
  
  BD Announces Voluntary Recall on Intraosseous Products

  
    
        When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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  Company Announcement Date:
             June 22, 2022

                          FDA Publish Date: 
               June 22, 2022
                                    Product Type: 
              Medical Devices
                          Reason for Announcement:
              Recall Reason Description
              Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries

            Company Name: 
              BD

            Brand Name:
              Brand Name(s)
          BD

            Product Description:
              Product Description
          Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers   
Company Announcement



**FRANKLIN LAKES, N.J. (June 22, 2022)**– BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM

Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers.

Certain lots within the expiration date of these intraosseous products may result in the following:

These issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries.

Impacted products include:

**Product Name**
			**Catalog No.**
			**UDI**
			**Lot No.**
			**Expiration Date**
			**Product Package Size**Needle Kit for Powered Driver 15mm x 15Ga
			D015151NK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageManual Driver Needle Kit 15mm x 15Ga
			D015151MK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageNeedle Kit for Powered Driver 25mm x 15Ga
			D015251NK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageManual Driver Needle Kit 25mm x 15Ga
			D015251MK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageNeedle Kit for Powered Driver 35mm x 15Ga
			D015351NK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageManual Driver Needle Kit 35mm x 15Ga
			D015351MK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageNeedle Kit for Powered Driver 45mm x 15Ga
			D015451NK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageManual Driver Needle Kit 45mm x 15Ga
			D015451MK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageNeedle Kit for Powered Driver 55mm x 15Ga
			D015551NK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageManual Driver Needle Kit 55mm x 15Ga
			D015551MK
			See appendix 1
			See appendix 1
			See appendix 1
			1 device per packageIntraosseous Powered Driver (drill)
			D001001
			00801741163579
			All
			All
			1 device per package

Customers should immediately review their inventory for the catalog and lot numbers listed above. Affected needle kits should be destroyed in compliance with the health care institution’s process for disposal. The use of affected intraosseous powered drivers should be paused until a BD representative provides instruction that it is safe for use. BD representatives will be reaching out to customers for inspection and will repair the devices if required.

There are no replacement products currently. BD recommends that customers evaluate their clinical needs and consider obtaining and using an alternative intraosseous product. BD will notify customers when replacement products become available.

Full customer and distributor letters can be found on the recall notification section of BD.com.

BD remains fully committed to ensuring patient and user safety. Customers requiring additional assistance or guidance may contact a service representative at 1-844-823-5433 Monday through Friday between 8 a.m. and 5 p.m. Central Time by saying “Recall” when prompted or via email at productcomplaints@bd.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online
	Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178**Appendix 1**

**Catalog Number**
			**Lot / Serial Number**
			**UDI (GTIN, DI + PI), if applicable**
			**Date of Manufacture**
			**Expiration Date**D015151NK
			121460
			801741163586
			09/10/2019
			09/10/2022D015251NK
			121496
			801741163678
			09/13/2019
			09/13/2022D015451NK
			121593
			801741163609
			09/26/2019
			09/26/2022D015251NK
			122096
			801741163678
			12/06/2019
			01/01/2023D015151NK
			122145
			801741163586
			12/11/2019
			01/01/2023D015451NK
			122169
			801741163609
			12/17/2019
			01/01/2023D015251MK
			122193
			801741163630
			12/30/2019
			01/02/2023D015151MK
			122359
			801741163623
			01/21/2020
			01/21/2023D015451MK
			122375
			801741163654
			01/22/2020
			01/22/2023D015451NK
			123305
			801741163609
			05/18/2020
			05/18/2023D015251NK
			123306
			801741163678
			05/18/2020
			05/18/2023D015151NK
			123307
			801741163586
			05/18/2020
			05/18/2023D015451MK
			123433
			801741163654
			06/02/2020
			06/02/2023D015451NK
			125016
			801741163609
			12/07/2020
			12/07/2023D015151NK
			125298
			801741163586
			01/22/2021
			01/22/2024D015251NK
			125299
			801741163678
			01/22/2021
			01/22/2024D015451NK
			125517
			801741163609
			02/09/2021
			02/09/2024D015251NK
			125533
			801741163678
			02/10/2021
			02/10/2024D015151NK
			125534
			801741163586
			02/10/2021
			02/10/2024D015251NK
			125535
			801741163678
			02/10/2021
			02/10/2024D015151NK
			125662
			801741163586
			02/25/2021
			02/25/2024D015351NK
			125721
			801741163593
			03/02/2021
			03/30/2024D015451NK
			125770
			801741163609
			03/05/2021
			03/05/2024D015551NK
			125841
			801741163616
			03/10/2021
			03/10/2024D015351MK
			125842
			801741163647
			03/10/2021
			03/10/2024D015551MK
			125843
			801741163661
			03/10/2021
			03/10/2024D015451NK
			125977
			801741163609
			03/22/2021
			03/22/2024D015251NK
			126075
			801741163678
			03/30/2021
			03/30/2024D015151NK
			126095
			801741163586
			04/05/2021
			04/08/2024D015251NK
			126149
			801741163678
			04/06/2021
			04/06/2024D015251NK
			126178
			801741163678
			04/12/2021
			04/12/2024D015451NK
			126299
			801741163609
			04/20/2021
			04/20/2024D015451NK
			126300
			801741163609
			04/20/2021
			04/20/2024D015451NK
			126340
			801741163609
			04/27/2021
			04/27/2024D015151NK
			126467
			801741163586
			05/10/2021
			05/10/2024D015251NK
			126569
			801741163678
			05/17/2021
			05/17/2024D015451NK
			126575
			801741163609
			05/17/2021
			05/17/2024D015151NK
			126677
			801741163586
			05/25/2021
			05/25/2024D015251NK
			126686
			801741163678
			05/26/2021
			05/26/2024D015551MK
			126834
			801741163661
			06/07/2021
			06/07/2024D015351NK
			126901
			801741163593
			06/11/2021
			06/11/2024D015351NK
			126939
			801741163593
			06/16/2021
			06/16/2024D015551NK
			126951
			801741163616
			06/17/2021
			06/17/2024D015551NK
			127003
			801741163616
			06/22/2021
			06/22/2024D015151NK
			127040
			801741163586
			06/24/2021
			06/24/2024D015451NK
			127092
			801741163609
			06/28/2021
			06/28/2024D015251NK
			127118
			801741163678
			07/01/2021
			07/01/2024D015451NK
			127119
			801741163609
			07/01/2021
			07/01/2024D015251NK
			127170
			801741163678
			07/07/2021
			07/07/2024D015451NK
			127300
			801741163609
			07/22/2021
			07/22/2024D015251NK
			127417
			801741163678
			08/04/2021
			08/04/2024D015551NK
			127496
			801741163616
			08/11/2021
			08/11/2024D015451NK
			127516
			801741163609
			08/12/2021
			08/12/2024D015151NK
			127711
			801741163586
			08/27/2021
			08/27/2024D015251NK
			127756
			801741163678
			09/01/2021
			09/01/2024D015451NK
			127808
			801741163609
			09/07/2021
			09/07/2024D015251NK
			128001
			801741163678
			09/21/2021
			09/21/2024D015151NK
			128002
			801741163586
			09/21/2021
			09/21/2024D015451NK
			128120
			801741163609
			10/01/2021
			10/01/2024D015151NK
			128208
			801741163586
			10/12/2021
			10/12/2024D015351NK
			128385
			801741163593
			10/27/2021
			10/27/2024D015251NK
			128482
			801741163678
			11/03/2021
			11/03/2024D015451NK
			128487
			801741163609
			11/03/2021
			11/03/2024D015551NK
			128724
			801741163616
			12/01/2021
			12/01/2024D015451NK
			128725
			801741163609
			12/01/2021
			12/01/2024D015151NK
			128778
			801741163586
			12/06/2021
			12/06/2024D015251NK
			128829
			801741163678
			12/07/2021
			12/07/2024

**About BD**

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

**Contacts:**

Media:
Troy Kirkpatrick
VP, Public Relations
858.617.2361troy.kirkpatrick@bd.com

Investors
Francesca DeMartino
SVP, Head of Investor Relations
201.847.5743francesca.demartino@bd.com





Company Contact Information
  
  
    Consumers:       

        
                 1-844-823-5433
        
                 productcomplaints@bd.com.
    Media:
      
              Troy Kirkpatrick, VP, Public Relations
      
              858-617-2361
      
              troy.kirkpatrick@bd.com

                                                                                  Content current as of:
      06/22/2022
               
             
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