The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Reason for recall: The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures. Distribution: Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA. Quantity: 1,243,937 Lot/code info: REF/UDI-DI/Lot (Expiration Date): 1410MSK/ 00801741142543/ 0001418630(05/28/24), 0001429851(07/28/24), 0001433778(08/28/24), 0001441794(10/28/24), 0001443076(10/28/24, 0001446454(11/28/24, 0001451131(01/28/25, 0001452840(01/28/25, 0001463142(03/28/25, 0001468867(04/28/25, 0001475757(06/28/25, 0001481508(07/28/25, 0001485193(08/28/25, 0001487094(08/28/25, 0001488512(08/28/25, 0001491080(09/28/25, 0001491583(09/28/25, 0001498859(11/28/25, 0001502349(12/28/25); 1416MSK/ 00801741142550/0001402196(01/28/24), 0001423061(06/28/24), 0001430525(07/28/24), 0001434059(08/28/24), 0001435619(09/28/24), 0001452376(01/28/25), 0001458437(02/28/25), 0001464693(03/28/25), 0001464694(03/28/25); 1610MSK/ 00801741142567/0001390419(10/28/23), 0001392740(10/28/23), 0001402197(01/28/24), 0001415815(04/28/24), 0001418632(05/28/24), 0001426735(06/28/24), 0001426839(07/28/24), 0001430408(07/28/24), 0001430528(07/28/24), 0001433779(08/28/24), 0001468480(04/28/25), 0001468479(04/28/25), 0001474221(05/28/25), 0001478981(06/28/25), 0001481036(07/28/25), 0001481035(07/28/25), 0001480804(07/28/25), 0001480805(07/28/25), 0001485185(08/28/25), 0001487093(08/28/25), 0001486540(08/28/25), 0001491078(09/28/25), 0001502344(12/28/25); 1616MSK/ 00801741142574/0001410073(02/28/24), 0001418633(05/28/24), 0001429719(07/28/24), 0001432764(08/28/24), 0001441990(10/28/24), 0001445629(11/28/24), 0001451613(01/28/25), 0001468728(04/28/25), 0001474220(05/28/25), 0001474506(05/28/25), 0001476311(06/28/25), 0001480541(07/28/25
00801741142543, 00801741142550, 00801741142567, 00801741142574, 00801741097058, 00801741097065, 00801741097072, 00801741142581, 00801741097089, 00801741097096, 00801741097102
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.