FDA Reports BD’s Recall of Intraosseous Products
On June 22, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-recall-intraosseous-products?utm_medium=email&utm_source=govdelivery) 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 |
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 (mailto:productcomplaints@bd.com).
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) 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