FDA DeviceClass II

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

From the FDA notice · Read the official notice ↗ · All Becton Dickinson recalls

What to do

The agency's notice has the remedy and who to contact.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
4180000 units
Illnesses reported
None reported
Manufactured in
1 Becton Dr, Franklin Lakes, NJ, United States
Classification
Class II
Recall number
Z-0504-2026

In the FDA's words

Description
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975; Distribution: 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 quantity: 4180000 units
Hazard
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

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