BD Intraosseous Vascular Access System recallZ-1397-2022 · Bard Access Systems, Inc. · initiated Jun 20, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Access Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.
FDA root cause category: Process change control
What the company is doing
On 06/20/22 BD mailed or emailed recall notices to customers asking them to: 1)Quarantine all affected devices. Destroy needle kits and keep intraosseous drivers quarantined until they can be inspected and repaired, if required, by firm sales representatives. 2) Share this notice with all users within your facility and network and with any organization where the potentially affected products have been transferred. 3) There is no replacement product at this time. The firm will notify customers when replacement products are available. 4) If you purchased affected product from a distributor, contact this distributor for further instructions. 5) If you purchased products directly, complete and return the response form. 6) Distributors were asked to identify all customers within their distribution network that purchased any affected product and to provide a copy of the customer letter. Recall Notice: https://bdx.force.com/CC360/s/impactedproducts?language=en_US&id=7018a000001Gn1tAAC Customers requiring further assistance can contact the North American Regional Complaint Center 1-844-823-5433, say "Recall" when prompted, Mon-Fri 8:00AM-5:00PM CT or [email protected]
Recall details
- Recall number
- Z-1397-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 20, 2022
- Posted by the FDA
- Jul 22, 2022
- Recalling firm
- Bard Access Systems, Inc.
- Quantity
- 40,734
- Product code
- FMI
- FDA submissions
- K203193, K191976
- Distribution
- Distribution US nationwide and Canada.
Product description
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Catalog/UDI/Lot: D015151NK/801741163586/, 121460, 122145, 123307, 125298, 125534, 125662, 126095, 126467, 126677, 127040, 127711, 128002, 128208, 128778; D015151MK/801741163623/122359; D015251NK/801741163678/121496, 122096, 123306, 125299, 125533, 125535, 126075, 126149, 126178, 126569, 126686, 127118, 127170, 127417, 127756, 128001; 128482, 128829; D015251MK/801741163630/122193; D015351NK/801741163593/125721, 126901, 126939, 128385; D015351MK/801741163647/125842; D015451NK/801741163609/121593, 122169, 123305, 125016, 125517, 125770, 125977, 126299, 126300, 126340, 126575, 127092, 127119, 127300, 127516, 127808, 128120, 128487, 128725; D015451MK/801741163654/122375, 123433; D015551NK/801741163616/125841, 126951, 127003, 127496, 128724; D015551MK/801741163661/125843, 126834; D001001/00801741163579/All Lots
Devices named in this recall
11 devices in the FDA device registry whose identifier appears in the recall's code information.
- BD Intraosseous Vascular Access System D015251NKBard Access Systems, Inc. · Needle, hypodermic, single lumen2 recalls3 deaths47 reports
- BD Intraosseous Vascular Access System D015451NKBard Access Systems, Inc. · Needle, hypodermic, single lumen2 recalls1 death35 reports
- BD Intraosseous Vascular Access System D015151NKBard Access Systems, Inc. · Needle, hypodermic, single lumen2 recalls1 death9 reports
- BD Intraosseous Vascular Access System D001001Bard Access Systems, Inc. · Needle, hypodermic, single lumen1 recall55 reports
- BD Intraosseous Vascular Access System D015551NKBard Access Systems, Inc. · Needle, hypodermic, single lumen2 recalls1 death3 reports
- BD Intraosseous Vascular Access System D015351NKBard Access Systems, Inc. · Needle, hypodermic, single lumen2 recalls2 reports
- BD Intraosseous Vascular Access System D015151MKBard Access Systems, Inc. · Needle, hypodermic, single lumen1 recall0 reports
- BD Intraosseous Vascular Access System D015251MKBard Access Systems, Inc. · Needle, hypodermic, single lumen1 recall0 reports
- BD Intraosseous Vascular Access System D015351MKBard Access Systems, Inc. · Needle, hypodermic, single lumen1 recall0 reports
- BD Intraosseous Vascular Access System D015451MKBard Access Systems, Inc. · Needle, hypodermic, single lumen1 recall0 reports
- BD Intraosseous Vascular Access System D015551MKBard Access Systems, Inc. · Needle, hypodermic, single lumen1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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