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Becton Dickinson & Company: BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

Medical DevicesSource: FDA (device) · Date: 2025-11-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Becton Dickinson & Company
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Reason / hazard
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.
Recall initiated
2025-10-14
Code info
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
Product quantity
4180000 units
Voluntary mandated
Voluntary: Firm initiated
City
Franklin Lakes
State
NJ
Country
United States
Event id
97737
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