FDA-Device2025-11-26Class IIPROCESSING DEFECT
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Hazard
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
4180000 units
Manufactured in
1 Becton Dr, Franklin Lakes, NJ, United States
Products
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2026Want us to check the next one for you?
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