BD Announces Voluntary Recall on Intraosseous Products
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 | 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 [email protected].
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), | Date of | 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 |
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.
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SOURCE BD (Becton, Dickinson and Company)
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