Z-2461-2021Class II

BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E

Name: Z-2461-2021 BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Creator: Carefusion
Published: 2021-08-02
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2021-08-02 / Open, Classified / root cause: manufacturing process

FDA source

CAREFUSION began a recall of BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E on 2021-08-02. FDA classified it as Class II and gives the reason as "Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2461-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-02
Posted: 2021-09-13
Recalling firm: CareFusion 303, Inc
Product: BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Product code: FPA Set, Administration, Intravascular
Reason for recall: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 08/02/21, Urgent Medical Device Correction notices were mailed and emailed to consignees who were asked to notify recalling firm if this issue was experienced at 1-844-823-5433, [email protected] . Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device. If during priming the clinician encounters an occluded needle-free connector, take the following actions: 1) Depress the syringe plunger while the syringe is still attached to the needle-free connector. 2) If unable to depress the plunger, pull back on the syringe plunger and depress the syringe plunger again. Repeating this step may assist in opening the needle-free connector valve. 3) If the valve still is not open; without disconnecting the syringe male luer tip from the BD SmartSite valve surface, carefully unthread and rethread the syringe to partially disengage and reengage the syringe. Repeating this step up to three times may assist in opening the needle-free valve. Note: To maintain sterility, do not allow the syringe and needle-free valve to completely disconnect. 4) If previous steps do not open the valve, then open a new needle-free connector to replace the occluded connector. 5) After the steps above, proceed with the existing instructions for use. 6) Share this correction notification with all users within your facility network of the product to ensure they are also aware of this correction. 7) Complete and return the Customer Response Form. Distributors were asked to identify customers within their distribution network that purchased the affected product and to email an excel file listing of all customers to the recalling firm within 72 hours of receipt of this letter so the recalling firm can initiate customer notification. See online tool to support the identification of impacted lot numbers https://www.bd.com/MDS-21-4144
Quantity in commerce: 708,910
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.
Product codes and lots: Lots: 20025450 20025451 20025452 20025531 20025532 20025533 20025534 20026527 20026529 20026532 20026533 20026534 20065580 20065582 20065581 20075239 20075240 20075241 20075242 20075618 20075619 20075447 20075448 20075449 20075450 20075451 20075452 20075453 20075790 20075791 20075924 20075792 20085362 20085363 20085364 20085365 20085421 20085422 20085522 20085523 20095302 20095303 20095310 20095533 20095534 20095311 20095312 20116500 20116501 21016470 21016471 21016593 20035697 20066252 20066399 20076260 20095373 20095887 20105859 20105860 20105861 20106710 21019903 21019904 21019905

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2461-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2454-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2455-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2456-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2457-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2458-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2459-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2460-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2461-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2462-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2463-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2464-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2465-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2466-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2467-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13
Z-2468-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-13

Product code FPA

K970485Class IISmartsite Access PinIvac Medical Systems / cleared 1997-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)