ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code recall

Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

Quantity: 15,455 cables

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Becton, Dickinson and Company, Irvine, CA

Date

Wednesday, September 30

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Grand Cayman.

Status

Ongoing

Recall number

Z-3250-2026

Source

U.S. Food and Drug Administration