Bard Access Systems, Inc.: BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit

Company / brand

Bard Access Systems, Inc.

Product

BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK

Reason / hazard

After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy

Classification

Class I

Status

Ongoing

Distribution / sold at

US: MA, FL, IA, SC, IL, NY, UT, NJ, ID, IN, PA, CA, TX, OH, MO, VA, MD, NC, AL, MN, CO, KY, LA, NV, OK, MS, AZ, MI, GA, AR, KS, TN. OUS: CA, SG

Recall initiated

2026-07-30

Code info

REF/UDI-DI/Lot(Expiration): D015151NK/00801741163586/BSLC9275(2026-08-03), BSLC9563(2026-08-13), BSLC9567(2026-08-25), BSLC10103(2026-09-27), BSLC10516(2026-11-01), BSLC10526(2026-11-16), BSLC10872(2026-12-09), BSLC11216(2028-07-02), BSLC11456(2028-07-23); D015251NK/00801741163678/BSLC9467(2026-08-10), BSLC9575(2026-09-20), BSLC10105(2026-10-04), BSLC10522(2026-11-07), BSLC10868(2026-12-02), BSLC11212(2028-06-18), BSLC11454(2028-07-17), BSLC11463(2028-08-07), BSLC11884(2028-09-15), BSLC11890(2028-09-18), BSLC12082(2028-10-08), BSLC12115(2028-10-20), BSLC12123(2028-10-22); D015351NK/00801741163593/BSLC11458(2028-07-24); 00801741163678/BSLC9277(2026-08-04), BSLC9485(2026-08-12), BSLC9569(2026-08-26), BSLC10099(2026-09-07), BSLC10514(2026-10-16), BSLC10518(2026-10-21), BSLC10524(2026-11-08), BSLC10870(2026-12-03), BSLC10874(2028-06-12), BSLC11218(2028-07-07); D015451NK/00801741163609/BSLC9279(2026-08-06), BSLC9565(2026-08-17), BSLC9571(2026-09-07), BSLC10101(2026-09-17), BSLC10456(2026-10-14), BSLC10520(2026-10-22), BSLC10866(2026-11-21), BSLC11214(2028-06-23), BSLC11450(2028-07-09), BSLC11460(2028-07-31), BSLC11873(2028-08-13), BSLC11888(2028-09-25), BSLC12007(2028-10-02), BSLC12105(2028-10-15); D015551NK/00801741163616/BSLC9465(2026-08-07), BSLC9573(2026-09-26), BSLC10107(2026-10-02), BSLC10528(2026-11-20), BSLC11452(2028-07-10)

Product quantity

80,200

Voluntary mandated

Voluntary: Firm initiated

City

Salt Lake City

State

UT

Country

United States

Event id

99484

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