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Recall Observatory FDA recall evidence

Device product

BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.

Z-1509-2025

February 20, 2025

Class II

Product summary

Firm
BD SWITZERLAND SARL
Event
Event 96399
Status
Ongoing
Classification
Class II
Quantity
500 units
Official record key
device-enforcement:Z-1509-2025

Official wording

Reason: Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

Code information: Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700

Distribution pattern: U.S.: AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN. TX, UT, VA, WA, WV O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)