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U.S. Department of Health and Human Services

Class 1 Device Recall BD Alaris Pump Infusion Sets

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 Class 1 Device Recall BD Alaris Pump Infusion Setssee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3080-2026
Recall Event ID 99298
510(K)NumberK022209 
Product Classification Set, administration, intravascular - Product Code FPA
ProductBD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites 11426965* 10885403232558 50885403232556 BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites 2260-0500 7613203012591 37613203012608 BD Alaris Pump Infusion Set, PE Lined Tubing 24600-0007 10885403241970 50885403241978 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 2278-0500 10885403223266 50885403223264 BD Alaris Pump Infusion Blood Set, 200 Micron Filter 2477-0007 7613203019460 37613203019478 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, SmartSite Y-site 22603-B007T 10885403240942 50885403240940 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 24010-0007T 10885403271021 50885403271029 BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites 24301-0007T 10885403223198 50885403223196 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site 24601-B007T 10885403240959 50885403240957 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, Back Check Valve, 2 SmartSite Y- sites 22602-B007T 10885403240935 50885403240933 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 11426964 10885403232367 50885403232365 BD AlarisLVP 20D LOW SORB 2204-0007* 10885403199363 50885403199361 BD Alaris Pump Infusion Set 10015862 10885403221866 50885403221864 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 10010453 7613203021135 37613203021143 BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 11532269 10885403232343 50885403232341 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites 2202-0007* 10885403274039 50885403274037 BD Alaris Pump Infusion Set, 1.2 Micron Filter 2432-0007* 10885403232329 50885403232327 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10010454 7613203015806 37613203015814 BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 2465-0007 10885403221941 50885403221949 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 10015012 10885403233951 50885403233959 BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site 2441-0007 10885403235047 50885403235045 BD Alaris Pump Infusion Burette Set, Smallbore Tubing, SmartSite Port (Burette), 3 SmartSite Y-sites 11419365 10885403234736 50885403234734 BD Alaris Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite Y-sites 2423-0007 7613203020985 37613203020979 BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10813621 10885403234514 50885403234512 BD Alaris Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10010483 10885403232602 50885403232600 BD Alaris Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing 10013072 7613203021210 37613203021228 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 2 SmartSite Y-sites 10013361 10885403221965 50885403221963 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Back Check Valve, 2 SmartSite Y-sites 10013890 10885403232268 50885403232266 BD Alaris Pump Infusion Set, PE Lined Tubin
Code Information 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites 11426965* 10885403232558 50885403232556 BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites 2260-0500 7613203012591 37613203012608 BD Alaris Pump Infusion Set, PE Lined Tubing 24600-0007 10885403241970 50885403241978 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 2278-0500 10885403223266 50885403223264 BD Alaris Pump Infusion Blood Set, 200 Micron Filter 2477-0007 7613203019460 37613203019478 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, SmartSite Y-site 22603-B007T 10885403240942 50885403240940 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 24010-0007T 10885403271021 50885403271029 BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites 24301-0007T 10885403223198 50885403223196 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site 24601-B007T 10885403240959 50885403240957 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, Back Check Valve, 2 SmartSite Y- sites 22602-B007T 10885403240935 50885403240933 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 11426964 10885403232367 50885403232365 BD Alaris¿LVP 20D LOW SORB 2204-0007* 10885403199363 50885403199361 BD Alaris Pump Infusion Set 10015862 10885403221866 50885403221864 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 10010453 7613203021135 37613203021143 BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 11532269 10885403232343 50885403232341 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites 2202-0007* 10885403274039 50885403274037 BD Alaris Pump Infusion Set, 1.2 Micron Filter 2432-0007* 10885403232329 50885403232327 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10010454 7613203015806 37613203015814 BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 2465-0007 10885403221941 50885403221949 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 10015012 10885403233951 50885403233959 BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site 2441-0007 10885403235047 50885403235045 BD Alaris Pump Infusion Burette Set, Smallbore Tubing, SmartSite Port (Burette), 3 SmartSite Y-sites 11419365 10885403234736 50885403234734 BD Alaris Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite Y-sites 2423-0007 7613203020985 37613203020979 BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10813621 10885403234514 50885403234512 BD Alaris Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10010483 10885403232602 50885403232600 BD Alaris Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing 10013072 7613203021210 37613203021228 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 2 SmartSite Y-sites 10013361 10885403221965 50885403221963 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Back Check Valve, 2 SmartSite Y-sites 10013890 10885403232268 50885403232266 BD Alaris Pump Infusion Set, PE Lined Tubing 10015645 10885403227967 50885403227965 BD Alaris Pump Infusion Set 2 SmartSite Y-Sites 295 cm (116 in) 10062818 7613203019668 37613203019676 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, 2 Blunt Spikes 10821753 7613203019187 37613203019195 BD Alaris Pump Infusion Burette Set, SmartSite Port (Burette), 3 SmartSite Y-sites 11404930 7613203021197 37613203021204 BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites 10013361T 10885403223204 50885403223202 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Bonded Texium Closed Male, Luer with Priming Cap, Back Check Valve, 2 SmartSite Y-sites 10321213T 10885403228971 50885403228979 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Bonded Texium Closed Male Luer with priming cap 2120-0500 7613203012690 37613203012707 BD Alaris Pump Infusion Set, Back Check Valve, 2 VersaSafe Split Septum Y-sites 2200-0500 7613203012638 37613203012646 GEM V/NV PRIMARY 20DP 22000-B007T 10885403245022 50885403245020 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 2203-0500 7613203019200 37613203019218 BD Alaris Pump Infusion Set, 15 Micron Filter, Amber Tubing 2210-0500 7613203012614 37613203012622 GEM V/NV PRI W/2 INJ SITES 20 22600-0007T 10885403239595 50885403239593 BD Alaris Pump Infusion Set, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 2408-0500 10885403235030 50885403235038 GEM 10DP CKV 4WAY-STPCK 4SS 2420-0500 7613203012430 37613203012448 BD Alaris Pump Infusion Set, Back Check Valve, 2 SmartSite Y-sites 2428-0007 10885403220883 50885403220881 BD Alaris Pump Infusion Set, 2 Back Check Valves, 4 SmartSite Y-sites 2455-0500 7613203021296 37613203021303 BD Alaris Pump Infusion Set, SmartSite Y-site 2466-0007 10885403221958 50885403221956 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 2206-0007 7613203019224 37613203019232 BD Alaris Pump Infusion Set, Yellow-Striped Microbore Tubing
FEI Number 3012798826
Recalling Firm/
Manufacturer		 BD SWITZERLAND SARL
Terre Bonne Park A4
Route De Crassier 17
Eysins Switzerland
For Additional Information ContactAmanda Pearson
970-836-2687
Manufacturer Reason
for Recall		Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
FDA Determined
Cause 2		Device Design
ActionOn 08/19/2026, an "URGENT MEDICAL DEVICE CORRECTION" letter was sent via FedEx and other courier services informing customers that, the BD Alaris" Pump Module Model 8100, when used with some BD Alaris" Pump Infusion Sets at low flow rates or to deliver low bolus volumes, may perform worse than previously disclosed. Due to the difficulty in recognizing these performance issues, users may fail to identify them as the cause of clinically significant changes in a patient's condition. Performance attributes that differ from previously communicated values have the potential to result in greater degrees of under / overinfusion, delayed time to occlusion alarms, and bolus dose inaccuracies. The Recall Notificaiton provides Clinical Recommendations for Sets with Updated Performance. Customers are instructed to: Immediately discard any sets listed within Attachment C: Discontinued Alaris" Pump Sets per your facility s procedures. a. To receive credit for discarded product, please return the completed Customer Response Form attached to this notice. If a set is included on Attachment C as discontinued, identify an alternate BD Alaris" Pump infusion set that is clinically appropriate and specific to the use case. If alternate sets are limited in quantity, they should be prioritized for use in critical-care, neonatal, infant, and pediatric care areas. 1. Review Attachments A, B, C and D and make any necessary adjustments to clinical use or set selection. Forward this communication to all areas of the facility where sets are being used. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. For questions or assistance- contact BD Technical Support at 866-488-1408 Phone hours: 5:00 am to 5:00 pm PT Monday Friday Create a case at: https://bd.com/self-service or Alarismedicalaffairs@bd.com for clinical questions.
Quantity in Commerce94,230,757
DistributionU.S.: Nation-wide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia Belgium Bahrain Botswana Canada Cuba China France Germany Gibraltar Israel India Italy Japan Korea, Republic of Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore South Africa Switzerland Taiwan, Province of China Turkey United Arab Emirates United Kingdom
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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