Pacific Medical Group Inc. recalls Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260

Recall date

September 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0980-2020

FDA classification

Class II

Brand / firm

Pacific Medical Group Inc.

Sold / distributed

U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE

Why it was recalled

Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260