Device product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Z-0504-2026
Product summary
- Event
- Event 97737
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4180000 units
- Official record key
device-enforcement:Z-0504-2026
Official wording
Reason: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Code information: Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
Distribution pattern: 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.
Derived failure modes
-
Unknown
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.