Z-0351-2024Class II

BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1...

Name: Z-0351-2024 BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1...
Creator: Becton Dickinson & Company
Published: 2023-10-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-10-11 / Open, Classified / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of 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... on 2023-10-11. FDA classified it as Class II and gives the reason as "Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0351-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-11
Posted: 2023-11-17
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0351-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0349-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17
Z-0350-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17
Z-0351-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17

Product code FPA

K022209Class IIAlaris Medical Infusion System Administration SetsAlaris Medical Systems, Inc. / cleared 2002-08-06

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)