Elekta Instrument AB: Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part

Hazard

The incorrect IFU was distributed with the devices.

Details from the source

Reason for recall: The incorrect IFU was distributed with the devices. Distribution: US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. There was also government distribution. Quantity: 70 devices Lot/code info: UDI-DI: (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and (12) 07340048306348.

UPC codes

07340048301305, 07340048300285, 07340048301220, 07340048301145, 07340048300315, 07340048308618, 07340048308632, 07340048308571, 07340048308564, 07340048308601, 07340048308625, 07340048306348

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.