Z-0979-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- September 19, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 772
Product Description
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
Reason for Recall
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Distribution Pattern
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
Code Information
All serial numbers sold between 02/06/2016 - 04/30/2019