| | Class 2 Device Recall Texium CSTD |  |
| Date Initiated by Firm | May 12, 2025 |
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| Date Posted | June 12, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1971-2025 |
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| Recall Event ID |
96737 |
| 510(K)Number | K071108 |
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| Product Classification |
Syringe, piston - Product Code FMF
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| Product | BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060 |
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| Code Information |
UDI-DI/Lot(Expiration):
MY8003/10885403221651/23125144(December 5, 2026), 24015468(January 20, 2027), 24025611(February 5, 2027), 24026390(February 27, 2027), 24036107(March 25, 2027), 24045647(April 24, 2027), 24055859(May 27, 2027), 24095513(September 24, 2027), 92217803(June 27, 2025), 92225801(September 15, 2025), 92231303(November 9, 2025), 92300201(January 2, 2026), 92308702(March 28, 2026), 92309501(April 5, 2026), 92313601(May 16, 2026), 92315701(June 6, 2026)
MY8005/10885403221668/23125145(December 5, 2026), 24015467(January 20, 2027), 24026387(February 27, 2027), 24045646(April 24, 2027), 24055858(May 27, 2027), 24075164(July 26, 2027), 24095512(September 24, 2027), 92215201(June 1, 2025), 92220802(July 27, 2025), 92225502(September 12, 2025), 92315102(May 31, 2026);
MY8010/10885403221675/24015312(January 15, 2027), 24025610(February 5, 2027), 24045645(April 24, 2027), 24055857(May 27, 2027), 24066953(June 25, 2027), 24075165(July 26, 2027), 24085486(August 26, 2027), 24095511(September 24, 2027), 24105167(October 25, 2027), 92218601(July 5, 2025), 92222902(August 17, 2025), 92223601(August 24, 2025), 92229201(October 19, 2025), 92230701(November 3, 2025), 92231301(November 9, 2025), 92231302(November 9, 2025), 92307402(March 15, 2026), 92311601(April 26, 2026), 92315101(May 31, 2026);
MY8020/10885403221682/23115069(November 3, 2026), 24015311(January 15, 2027), 24025935(February 7, 2027), 24035566(March 5, 2027), 24036106(March 25, 2027), 24045644(April 24, 2027), 24055856(May 27, 2027), 24066952(June 25, 2027), 24075163(July 26, 2027), 24085485(August 26, 2027), 24095083(September 9, 2027), 24105196(October 30, 2027), 92216401(June 13, 2025), 92217801(June 27, 2025), 92218001(June 29, 2025), 92219202(July 11, 2025), 92231901(November 15, 2025), 92300205(January 2, 2026), 92300902(January 9, 2026), 92309503(April 5, 2026), 92310101(April 11, 2026), 92313002(May 10, 2026), 92313602(May 16, 2026)
MY8030/10885403230523/23115070(November 3, 2026), 23125143(December 5, 2026), 24015264(January 12, 2027), 24015644(January 27, 2027), 24026389(February 27, 2027), 24036105(March 25, 2027), 24045643(April 24, 2027), 24055855(May 27, 2027), 24075162(July 26, 2027), 24085484(August 26, 2027), 24095509(September 24, 2027), 24115110(November 5, 2027), 92225501(September 12, 2025), 92233602(December 2, 2025), 92307403(March 15, 2026), 92308701(March 28, 2026), 92309502(April 5, 2026), 92315702(June 6, 2026), 92316402(June 13, 2026), 24066951(June 25, 2027);
MY8060/10885403221699/23115496(November 28, 2026), 23125393(December 18, 2026), 24015102(January 8, 2027), 24026388(February 27, 2027), 24036104(March 25, 2027), 24045366(April 23, 2027), 24055854(May 27, 2027), 24075166(July 26, 2027), 24095596(September 24, 2027), 24115111(November 14, 2027), 92216402(June 13, 2025), 92222002(August 8, 2025), 92222901(August 17, 2025), 92224303(August 31, 2025), 92224301(August 31, 2025), 92226502(September 22, 2025), 92228501(October 12, 2025), 92230702(November 3, 2025), 92230703(November 3, 2025), 92230704(November 3, 2025), 92300202(January 2, 2026), 92300203(January 2, 2026), 92306703(March 8, 2026), 92306701(March 8, 2026), 92306702(March 8, 2026), 92311602(April 26, 2026), 92312302(May 3, 2026), 92313001(May 10, 2026), 92316601(June 15, 2026), 92316602(June 15, 2026)
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| FEI Number |
3012798826
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Recalling Firm/
Manufacturer |
BD SWITZERLAND SARL
Terre Bonne Park A4
Route De Crassier 17
Eysins Switzerland
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| 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
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| Quantity in Commerce | 1,265,400 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = FMF
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