BD SWITZERLAND SARL: Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

Recall number

Z-1970-2025

Recalling firm

BD SWITZERLAND SARL

Product

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

Status

Open, Classified

Initiated

2025-05-12

Posted

2025-06-12

Terminated

not on file

Reason

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Root cause

Process control

Action

On 5/12/2025, removal notices were mailed or emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Nurse Managers, and Distributors who were asked to do the following: 1. Immediately review your inventory for affected product. Destroy all unused affected products subject to the recall following your institution s process for destruction. 2. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 3. Complete the Customer Response Form via email to bdrc53@bd.com 4. In addition, distributors were asked to identify all customers that purchased any affected product and to provide a copy of the customer letter to all customers and to advise them of the removal notification. Report any complaints experienced with the use of this product to the firm's North American Regional Complaint Center: Phone: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com

Quantity

2,024,780

Distribution

Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.

Lot, serial or model codes

REF/UDI-DI/Lot(Expiration): 10013361T/10885403223204/23025303(February 10, 2026), 23035235(March 11, 2026), 23045223(April 6, 2026), 23075395(July 17, 2026), 23085227(August 8, 2026), 23115150(November 8, 2026), 23115151(November 8, 2026), 23125167(December 5, 2026), 24025684(February 6, 2027), 24045377(April 23, 2027), 24055576(May 27, 2027), 24075224(July 26, 2027), 24105079(October 11, 2027), 24115159(November 7, 2027); 10321213T/10885403228971/23035169(March 15, 2026), 23045174(April 4, 2026), 23085140(August 3, 2026), 23095142(September 11, 2026), 23105297(October 12, 2026), 24025686(February 6, 2027); 22000-B007T/10885403245022/23025320(February 13, 2026), 23045224(April 11, 2026), 23065209(June 10, 2026), 23075394(July 21, 2026), 23095143(September 11, 2026), 23105133(October 6, 2026), 24015278(January 13, 2027), 24025685(February 6, 2027), 24036209(March 25, 2027), 24075260(July 26, 2027), 24066653(June 24, 2027); 22600-0007T/10885403239595/23095151(September 11, 2026), 24036205(March 25, 2027), 24055601(May 27, 2027); 22602-B007T/10885403240935/23045501(April 20, 2026), 23095152(September 11, 2026), 24015186(January 9, 2027), 24026152(February 27, 2027), 24036206(March 25, 2027), 24045384(April 23, 2027), 24115032(November 2, 2027); 22603-B007T/10885403240942/23035482(March 23, 2026), 23035504(March 25, 2026), 23055379(May 23, 2026), 23065210(June 12, 2026), 23075056(July 13, 2026), 23085141(August 3, 2026), 23095808(September 14, 2026), 23105296(October 12, 2026), 23125107(December 4, 2026), 24015185(January 9, 2027), 24025681(February 6, 2027), 24026153(February 27, 2027), 24026154(February 27, 2027), 24036207(March 25, 2027), 24045381(April 23, 2027), 24055577(May 27, 2027), 24066654(June 24, 2027), 24085243(August 26, 2027), 24095223(September 23, 2027), 24115312(December 2, 2027); 24010-0007T/10885403271021/23025108(February 8, 2026), 23035249(March 14, 2026), 23075392(July 18, 2026), 23085223(August 8, 2026), 23095763(September 19, 2026), 23105136(October 6, 2026), 23115054(November 3, 2026), 24015279(January 13, 2027), 24015386(January 17, 2027), 24025683(February 6, 2027), 24026149(February 27, 2027), 24045382(April 23, 2027), 24055598(May 27, 2027), 24075225(July 26, 2027), 24085240(August 26, 2027), 24095220(September 23, 2027), 24115311(November 14, 2027), 24066656(June 24, 2027); 24301-0007T/10885403223198/23025183(February 9, 2026), 23025238(February 10, 2026), 23035338(March 16, 2026), 23045222(April 12, 2026), 23075393(July 20, 2026), 23085226(August 8, 2026), 23095764(September 19, 2026), 23105284(October 11, 2026), 23115055(November 3, 2026), 24026089(February 21, 2027), 24026150(February 27, 2027), 24036178(March 25, 2027), 24045383(April 23, 2027), 24055599(May 27, 2027), 24075212(July 26, 2027), 24085241(August 26, 2027), 24095221(September 23, 2027), 24115279(November 12, 2027), 24015474(January 20, 2027); 24601-B007T/10885403240959/23035170(March 9, 2026), 23055380(May 24, 2026), 23065280(June 13, 2026), 23085142(August 3, 2026), 23095153(September 11, 2026), 23105285(October 11, 2026), 23115052(November 3, 2026), 24025682(February 6, 2027), 24026151(February 27, 2027), 24036208(March 25, 2027), 24055600(May 27, 2027), 24075261(July 26, 2027), 24085242(August 26, 2027), 24105106(October 22, 2027), 24066655(June 24, 2027), 24015475(January 20, 2027); 70001B-07T/10885403240997/24109019(October 2, 2027), 24109018(October 2, 2027), 24089215(August 9, 2027), 24089214(August 9, 2027), 24019266(January 16, 2027), 23109293(October 23, 2026), 24099179(September 5, 2027), 24049266(April 15, 2027), 24039248(March 14, 2027); 20350ET/10885403229756/24129026(November 13, 2027), 24079037(July 2, 2027), 24059361(May 15, 2027), 25029088(February 4, 2028), 24049028(April 2, 2027); 40000-07T/10885403225628/24119116(November 6, 2027), 24089019(August 1, 2027), 24079173(July 3, 2027), 24059480(May 28, 2027), 24059152(May 7, 2027), 24019267(January 16, 2027), 23119354(November 29, 2026), 24049267(April 15.2027), 24039212(March 12, 2027), 23109275(October 19, 2026), 23079215(July 20, 2026); 10013364T/10885403198915/24109021(October 2, 2027), 24109020(October 2, 2027), 24099172(September 5, 2027), 24089059(August 5, 2027), 24089058(August 4, 2027), 24079175(July 3, 2027), 24079174(July 3, 2027), 24059506(May 30, 2027), 24059469(May 28, 2027), 24059151(May 7, 2027), 24039059(March 4, 2027), 24019435(January 31, 2027), 24019268(January 16, 2027), 24019433(January 30, 2027), 24019269(January 16, 2027), 23119087(November 6, 2026), 23129229(December 13, 2026), 23129230(December 13, 2026), 23059178(May 24, 2026), 23059177(May 23, 2026), 23059156(May 16, 2026), 23049061(April 26, 2026), 24059150(May 7, 2027), 24049265(April 15, 2027), 23109175(October 13, 2026), 23109006(October 2, 2026), 23099219(September 12, 2026), 23099217(September 11, 2026), 23059179(May 29, 2026); 4030B-07T/10885403240867/24089216(August 9, 2027), 24059484(May 28, 2027), 24039060(March 4, 2027), 25029393(February 27, 2028), 23109296(October 23, 2026); 22005E-07T/10885403250781/23029335(February 24, 2026)

510(k) numbers

["K053049"]

PMA numbers

not on file

Product code

FPA

Firm FEI

3012798826

Firm city

Eysins

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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