FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
- Recall number
- Z-0350-2024
- Recalling firm
- Becton Dickinson & Company
- Product
- BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
- Status
- Open, Classified
- Initiated
- 2023-10-11
- Posted
- 2023-11-17
- Terminated
- not on file
- Reason
- Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- 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: productcomplaints@bd.com. Any adverse health consequences experienced may also be reported to the FDA's MedWatch Adverse Event Reporting program.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI: 10885403240867, Catalog # 4030B-07T; UDI-DI: 07613203020855, Catalog # 42081E. All lots, thru expiration date July 31, 2026.
- 510(k) numbers
- ["K022209","K882302"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28