Summary

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: 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 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:

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 package
Manual Driver Needle Kit 15mm x 15Ga D015151MK See appendix 1 See appendix 1 See appendix 1 1 device per package
Needle Kit for Powered Driver 25mm x 15Ga D015251NK See appendix 1 See appendix 1 See appendix 1 1 device per package
Manual Driver Needle Kit 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 [email protected].

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 09/10/2022
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:
Troy Kirkpatrick
VP, Public Relations
858.617.2361
[email protected]

Investors
Francesca DeMartino
SVP, Head of Investor Relations
201.847.5743
[email protected]


Company Contact Information