On June 22, 2022, the U.S. Food and Drug Administration (FDA) reported Becton, Dickinson and Company’s (BD’s) voluntary recall of its intraosseous needle set kits, manual driver kits, and powered drivers. Use of the products could lead to needlestick injuries or delays in care because of limited or non-functioning intraosseous access.

The following products are included in the recall:

Product Name

Catalog No.

UDI

Lot No.

Expiration Date

Product Package Size

Needle kit for powered driver 15 mm x 15 Ga

D015151NK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Manual driver needle kit 15 mm x 15 Ga

D015151MK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Needle kit for powered driver 25 mm x 15 Ga

D015251NK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Manual driver needle kit 25 mm x 15 Ga

D015251MK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Needle kit for powered driver 35 mm x 15 Ga

D015351NK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Manual driver needle kit 35 mm x 15 Ga

D015351MK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Needle kit for powered driver 45 mm x 15 Ga

D015451NK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Manual driver needle kit 45 mm x 15 Ga

D015451MK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Needle kit for powered driver 55 mm x 15 Ga

D015551NK

See appendix 1.

See appendix 1.

See appendix 1.

1 device per package

Manual driver needle kit 55 mm x 15 Ga

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

 

FDA Reports BD’s Recall of Intraosseous Products

Consumers should stop using the affected intraosseous powered drivers until further notice from BD. Providers should destroy the recalled needle kits in compliance with their healthcare institution’s disposal policies. FDA reported that BD representatives will reach out to customers for inspection and repair devices if required.

BD has not yet announced any replacement products and advised customers to consider using an alternative intraosseous product based on their clinical needs. FDA reported that BD will notify customers when replacement products become available.

Consumers requiring additional assistance can contact BD at 844-823-5433 Monday–Friday, from 8 am–5 pm CST, or by email at productcomplaints@bd.com.

Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.

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

DI—device identifier, GTIN—global trade item number, PI—production identifier, UDI—unique device identification