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U.S. Department of Health and Human Services

Class 2 Device Recall BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite YSites

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 Class 2 Device Recall BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite YSitessee related information
Date Initiated by FirmAugust 02, 2021
Create DateSeptember 13, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2466-2021
Recall Event ID 88203
510(K)NumberK960280 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Code Information Lots:  20077170 20077171 20077319 20077320
Recalling Firm/
Manufacturer
CAREFUSION
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer 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.
FDA Determined
Cause 2
Process control
ActionOn 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, productcomplaints@bd.com . 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 Commerce270
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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