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RecallWatchMedical Device Safety
Class IIOngoingZ-1970-2025

BD SWITZERLAND SARL recalls Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming C…

BD SWITZERLAND SARLEysins, SwitzerlandReported Jun 18, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites1 code
  • 10013361T
SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap1 code
  • 10321213T
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap1 code
  • 22000-B007T
Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap1 code
  • 22600-0007T
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap1 code
  • 22602-B007T
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap1 code
  • 22602-B007T
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap1 code
  • 22603-B007T
Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites1 code
  • 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-site1 code
  • 24301-0007T
SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites2 codes
  • 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING
  • 70001B-07T
BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium1 code
  • 20350ET
BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger1 code
  • 40000-07T
BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER1 code
  • 10013364T
BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION1 code
  • 4030B-07T
BD Texium Smartsite MICROBORE EXTENSION SET 60 IN1 code
  • 22005E-07T

Lot / code information

Lot #
(Expiration): 10013361T/10885403223204/23025303(February 10, 2026), 23035235(March 11, 2026), 23045223(April 6, 2026) — +328 moreShow all
(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)

What the firm is doing

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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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