FDA Recall Open, Classified

BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD SmartSite NEEDLE FREE VALVE, REF: 2000E; BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE, REF: 20021E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20035E; BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER, REF: 20037E; BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES, REF: 20038E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20039E; BD Extension Set SmartSite VALVE SLIP LUER, REF: 20057E; BD Extension Set SmartSite VALVE, REF: 20059E; BD extension Set Y-CONNECTOR 2 SmartSite VALVES, REF: 20061E; BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES, REF: 20062E; BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE, REF: 20159E; BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE, REF: 20338E; BD EXTENSION SET SmartSite VALVE, REF: 21059E; BD 8.5-IN PRESSURE RATED EXTENSION SET SmartSite VALVE, REF: 22003E-07; BD Texium SmartSite VALVE MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T; BD EXTENSION SET SmartSite VALVE (DETACHABLE), REF: 22059E; BD EXTENSION SET SmartSite VALVE (DETACHABLE) SLIP LUER, REF: C25015E; BD SmartSite Syringe-Syringe Transfer Device, REF: MV0450

Recall: Z-2460-2021 · Initiated August 2, 2021

Recall

Recall Number: Z-2460-2021
Event Number: 88203
Firm: CAREFUSION
FEI Number: 3012410077
Product Code: FPA
Status: Open, Classified
Root Cause: Process control
Initiated: August 2, 2021
Address: 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

Description

Reason

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.

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

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.

Quantity

20,874,700