Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Reason for recall: Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU) Distribution: 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 Quantity: 500 units Lot/code info: Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700
00382903949106
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.