Skip to content

BD Extension Sets (Product Name, Catalog #) recallZ-0351-2024 · Becton Dickinson & Company · initiated Oct 11, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

FDA root cause category: Error in labeling

What the company is doing

BD sent initial letters for this recall on October 11, 2023. A second notification was made available to customers on November 1, 2023 providing customers with additional information related to risk and recommended customer actions. In addition, the customer notification identified one additional product code that is in scope of this advisory. BD has identified that the infusion sets listed in Appendix 1 of the customer notification contain di(2-ethylhexyl) phthalate (DEHP) and have not been labelled accordingly. This could lead to the potential risk of DEHP exposure that may have short-term and long-term harmful effects. BD recommends using DEHP-free devices when specified by drug manufacturers. For devices in-situ with patients requiring a DEHP-free treatment, BD instructs to cease use and an alternate treatment or device be sourced. BD will be updating the labelling for these devices to state Contains or presence of phthalate: DEHP. Circulate this notice to all who need to be aware within your organization and to any organization affected devices have been further distributed to. Return the customer response from to BD whether or not you have any of the impacted material. Report any issues experienced with these devices to BD as a complaint as per your normal process. Phone: (844) 823-5433, Mon Fri 8:00am and 5:00pm CT, or Email: [email protected]. Any adverse health consequences experienced may also be reported to the FDA's MedWatch Adverse Event Reporting program.

Recall details

Recall number
Z-0351-2024
Status
Open, Classified
Initiated by the company
Oct 11, 2023
Posted by the FDA
Nov 17, 2023
Recalling firm
Becton Dickinson & Company
Product code
FPA
FDA submissions
K022209
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.

Product description

BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

Code information (models, lots, serial numbers)

UDI-DI: 10885403233814, Catalog # 10013902 UDI-DI: 07613203011853, Catalog # 20062E; UDI-DI: 10885403226120, Catalog # 70000N-07; UDI-DI: 10885403236112, Catalog # ME1224; UDI-DI: 10885403229756, Catalog # 20350ET; UDI-DI: 10885403240997, Catalog # 70001B-07T. All lots, thru expiration date October 16, 2026.

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93266).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page