Z-1970-2025Class II

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2...

Name: Z-1970-2025 Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2...
Creator: Bd Switzerland Sarl
Published: 2025-05-12
License: https://open.fda.gov/license/

BD Switzerland SARL / initiated 2025-05-12 / Open, Classified / root cause: manufacturing process

FDA source

BD SWITZERLAND SARL began a recall of 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... on 2025-05-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1970-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-12
Posted: 2025-06-12
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
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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: [email protected]
Quantity in commerce: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1970-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1970-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1971-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1972-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1973-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12
Z-1974-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code FPA

K053049Class IIAlaris Safety Male LuerCardinal Health, Alaris Products / cleared 2006-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)