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 f…
Bard Access Systems, Inc. · After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary…
Open FDA's page for this record- Cfres ID
- 221651
- Product res number
- Z-2872-2026
- Event date initiated
- 2026-07-30
- Event date posted
- 2026-08-14
- Recall status
- Open, Classified
- Res event number
- 99484
- Product code
- FMI
- Firm FEI number
- 3006260740
- Recalling firm
- Bard Access Systems, Inc.
- Address 1
- 605 N 5600 W
- City
- Salt Lake City
- State
- UT
- Postal code
- 84116-3738
- Additional info contact
- 801-522-5000
- Root cause description
- Component change control
- Product quantity
- 80,200
- Distribution pattern
- 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
- Product description
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
- 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)
- Reason for recall
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
- Action
On 7/30/2026, recall notices were mailed/emailed: If rotation and locking occurs, the clinician may need to obtain a new IO needle or other form of vascular access device, such as a Peripheral IV catheter. Alternate vascular access approaches, including additional peripheral IV attempts, or central venous access may continue to be pursued based on clinical judgment/protocols. Affected product should not be used to establish IO access. For patients in whom potentially affected intraosseous needles are currently in use/or have been used and are/were functioning properly, no additional steps need to be taken. 1. Destroy all affected needle set kits, or quarantined until disposal. 2. Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. 3. Complete and return the attached Customer Response Form via email to bdrc16@bd.com Distributors were also asked to do the following: - A customer letter template is provided to create your own letter to be sent to all customers. - Provide product replacement for all product destroyed by your customer. Questions contact firm at 1-844-823-5433 or productcomplaints@bd.com Firm has acquired new molds with improved dimensional controls. Instructions For Use will be updated with the following to optimize needle / obturator(stylet) / drill handling: Do not pull back on the drill and needle, release the trigger prematurely, or rock/bend the needle during insertion. These actions may result in the needle and drive adapter hubs to rotate and lock together resulting in a bent needle, difficult stylet removal, need for a new device, and/or delay in therapy. Warning: Do not rotate or try to unscrew the drive adapter hub while removing the stylet. These actions may cause the needle and drive adapter hubs to rotate and lock together, resulting in difficult stylet removal, need for a new device, and/or delay in therapy.
- K numbers
- K191976, K203193
- Harmonized identifiers (openFDA)
- Device name
- Needle, Hypodermic, Single Lumen
- Medical specialty description
- General Hospital
- Regulation number
- 880.5570
- Device class
- 2
- K number
- K970383, K960933, K936029, K102584, K220603, K951515, K142765, K813648, K230635, K052843, K881654, K925086, K180545, K052408, K761098, K861318, K233037, K131954, K100124, K170824, K934435, K943794, K021315, K944114, K001853, K024109, K915409, K905664, K160887, K925056, K152877, K904295, K002180, K231723, K062956, K890620, K061032, K000085, K891919, K132583 +654 more
- Registration number
- 3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1836161, 1017768, 3004458481, 3006973666, 3004143450, 3017509841, 2032098, 1319211, 3010872792, 3016884191, 3003916417, 3015727296, 3014479313, 3009853488, 9610847, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 9614279, 3007007790, 2027487, 1000523114 +414 more
- FEI number
- 3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3010862763, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1017768, 3004458481, 3006973666, 1000112877, 3008002452, 3004143450, 3017509841, 1319211, 3001570557, 3010872792, 3016884191, 3003169040, 3004521048, 1000174591, 3015727296, 3014479313, 3009853488, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 3007007790 +414 more
