FDAClass IIFebruary 12, 2020

Pacific Medical GE Corometrics Nautilus Toco Transducer recall

Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205

Why was Pacific Medical GE Corometrics Nautilus Toco Transducer recalled?

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

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 sold between 02/06/2016 - 04/30/2019

Product
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Recalling firm
Pacific Medical Group Inc.
Quantity
772
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)
Open FDA enforcement record Latest recalls