Safety Report: Intraosseous Products - recalled due to limited or non-functioning intraosseous access, USA

United States

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:

- Needle Kit for Powered Driver 15mm x 15Ga. Catalog No.: D015151NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 15mm x 15Ga. Catalog No.: D015151MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 25mm x 15Ga. Catalog No.: D015251NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 25mm x 15Ga. Catalog No.: D015251MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 35mm x 15Ga. Catalog No.: D015351NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 35mm x 15Ga. Catalog No.: D015351MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 45mm x 15Ga. Catalog No.: D015451NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 45mm x 15Ga. Catalog No.: D015451MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 55mm x 15Ga. Catalog No.: D015551NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 55mm x 15Ga. Catalog No.: D015551MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Intraosseous Powered Driver (drill). Catalog No.: D001001. UDI: 801741163579. Lot No.: All. Expiration Date All. Product Package Size: 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. There are no replacement products currently.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: BD
Brand name: BDTM
Product recalled: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers
Reason of the recall: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries
FDA Recall date: June 22, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-recall-intraosseous-products