Press Release

BD Announces Voluntary Recall on Intraosseous Products

Jun 22, 2022

FRANKLIN LAKES, N.J., June 22, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BD™ Intraosseous Needle Set Kits, BD™ Intraosseous Manual Driver Kits and BD™ Intraosseous Powered Drivers.

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

  • Difficulty separating the stylet from the intraosseous needle, where increased force required to remove the stylet from the intraosseous needle results in inadvertent removal of the entire needle assembly during placement or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access.
  • Needle safety mechanism on the stylet not deploying post placement of the intraosseous needle and removal of the stylet from the needle.
  • Metal discs intended to connect the needle assembly to the magnet in the powered driver sticking unexpectedly to the magnet, rendering the driver unable to be used.

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 PoweredDriver 15mm x 15Ga

D015151NK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Manual Driver NeedleKit 15mm x 15Ga

D015151MK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Needle Kit for PoweredDriver 25mm x 15Ga

D015251NK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Manual Driver NeedleKit 25mm x 15Ga

D015251MK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Needle Kit for Powered Driver 35mm x 15Ga

D015351NK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Manual Driver Needle Kit 35mm x 15Ga

D015351MK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Needle Kit for Powered Driver 45mm x 15Ga

D015451NK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Manual Driver Needle Kit 45mm x 15Ga

D015451MK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Needle Kit for Powered Driver 55mm x 15Ga

D015551NK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Manual Driver Needle Kit 55mm x 15Ga

D015551MK

See appendix 1

See appendix 1

See appendix 1

1 device per package

Intraosseous 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.

Any adverse health consequences experienced with the use of these products should be reported immediately. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via:

Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA-1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-9787

Appendix 1

Catalog Number

Lot / Serial Number

UDI (GTIN, DI + PI),
if applicable

Date of
Manufacture

Expiration Date

D015151NK

121460

801741163586

09/10/2019

09/10/2022

D015251NK

121496

801741163678

09/13/2019

09/13/2022

D015451NK

121593

801741163609

09/26/2019

09/26/2022

D015251NK

122096

801741163678

12/06/2019

01/01/2023

D015151NK

122145

801741163586

12/11/2019

01/01/2023

D015451NK

122169

801741163609

12/17/2019

01/01/2023

D015251MK

122193

801741163630

12/30/2019

01/02/2023

D015151MK

122359

801741163623

01/21/2020

01/21/2023

D015451MK

122375

801741163654

01/22/2020

01/22/2023

D015451NK

123305

801741163609

05/18/2020

05/18/2023

D015251NK

123306

801741163678

05/18/2020

05/18/2023

D015151NK

123307

801741163586

05/18/2020

05/18/2023

D015451MK

123433

801741163654

06/02/2020

06/02/2023

D015451NK

125016

801741163609

12/07/2020

12/07/2023

D015151NK

125298

801741163586

01/22/2021

01/22/2024

D015251NK

125299

801741163678

01/22/2021

01/22/2024

D015451NK

125517

801741163609

02/09/2021

02/09/2024

D015251NK

125533

801741163678

02/10/2021

02/10/2024

D015151NK

125534

801741163586

02/10/2021

02/10/2024

D015251NK

125535

801741163678

02/10/2021

02/10/2024

D015151NK

125662

801741163586

02/25/2021

02/25/2024

D015351NK

125721

801741163593

03/02/2021

03/30/2024

D015451NK

125770

801741163609

03/05/2021

03/05/2024

D015551NK

125841

801741163616

03/10/2021

03/10/2024

D015351MK

125842

801741163647

03/10/2021

03/10/2024

D015551MK

125843

801741163661

03/10/2021

03/10/2024

D015451NK

125977

801741163609

03/22/2021

03/22/2024

D015251NK

126075

801741163678

03/30/2021

03/30/2024

D015151NK

126095

801741163586

04/05/2021

04/08/2024

D015251NK

126149

801741163678

04/06/2021

04/06/2024

D015251NK

126178

801741163678

04/12/2021

04/12/2024

D015451NK

126299

801741163609

04/20/2021

04/20/2024

D015451NK

126300

801741163609

04/20/2021

04/20/2024

D015451NK

126340

801741163609

04/27/2021

04/27/2024

D015151NK

126467

801741163586

05/10/2021

05/10/2024

D015251NK

126569

801741163678

05/17/2021

05/17/2024

D015451NK

126575

801741163609

05/17/2021

05/17/2024

D015151NK

126677

801741163586

05/25/2021

05/25/2024

D015251NK

126686

801741163678

05/26/2021

05/26/2024

D015551MK

126834

801741163661

06/07/2021

06/07/2024

D015351NK

126901

801741163593

06/11/2021

06/11/2024

D015351NK

126939

801741163593

06/16/2021

06/16/2024

D015551NK

126951

801741163616

06/17/2021

06/17/2024

D015551NK

127003

801741163616

06/22/2021

06/22/2024

D015151NK

127040

801741163586

06/24/2021

06/24/2024

D015451NK

127092

801741163609

06/28/2021

06/28/2024

D015251NK

127118

801741163678

07/01/2021

07/01/2024

D015451NK

127119

801741163609

07/01/2021

07/01/2024

D015251NK

127170

801741163678

07/07/2021

07/07/2024

D015451NK

127300

801741163609

07/22/2021

07/22/2024

D015251NK

127417

801741163678

08/04/2021

08/04/2024

D015551NK

127496

801741163616

08/11/2021

08/11/2024

D015451NK

127516

801741163609

08/12/2021

08/12/2024

D015151NK

127711

801741163586

08/27/2021

08/27/2024

D015251NK

127756

801741163678

09/01/2021

09/01/2024

D015451NK

127808

801741163609

09/07/2021

09/07/2024

D015251NK

128001

801741163678

09/21/2021

09/21/2024

D015151NK

128002

801741163586

09/21/2021

09/21/2024

D015451NK

128120

801741163609

10/01/2021

10/01/2024

D015151NK

128208

801741163586

10/12/2021

10/12/2024

D015351NK

128385

801741163593

10/27/2021

10/27/2024

D015251NK

128482

801741163678

11/03/2021

11/03/2024

D015451NK

128487

801741163609

11/03/2021

11/03/2024

D015551NK

128724

801741163616

12/01/2021

12/01/2024

D015451NK

128725

801741163609

12/01/2021

12/01/2024

D015151NK

128778

801741163586

12/06/2021

12/06/2024

D015251NK

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:

Investors:

Troy Kirkpatrick  

Francesca DeMartino

VP, Public Relations

SVP, Head of Investor Relations

858.617.2361  

201.847.5743        

troy.kirkpatrick@bd.com 

francesca.demartino@bd.com    

 

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SOURCE BD (Becton, Dickinson and Company)