- 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:
- Brand Name:
- Product Description:
Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers
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:
- 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 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
Lot / Serial Number
UDI (GTIN, DI + PI), if applicable
Date of Manufacture
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.
VP, Public Relations
SVP, Head of Investor Relations
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