Pacific Medical GE Corometrics Nautilus Toco Transducer recall
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Why was Pacific Medical GE Corometrics Nautilus Toco Transducer 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers distributed between 02/06/16 - 04/30/19.
- Product
- Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
- Recalling firm
- Pacific Medical Group Inc.
- Quantity
- 628
- Distribution
- 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
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)