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Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driv...

FDA Device Recall #Z-1397-2022 — Class I — June 20, 2022

Recall Summary

Recall Number Z-1397-2022
Classification Class I — Serious risk
Date Initiated June 20, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Access Systems, Inc.
Location Salt Lake City, UT
Product Type Devices
Quantity 40,734

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)

Reason for Recall

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.

Distribution Pattern

Distribution US nationwide and Canada.

Lot / Code Information

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

Other Recalls from Bard Access Systems, Inc.

Recall # Classification Product Date
Z-1507-2025 Class I BD 4 Fr Single-Lumen PowerPICC Catheters, REF: ... Mar 11, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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