Z-2172-2021 Class III Ongoing
FDA device recall Z-2172-2021 was initiated by Verathon, Inc. on July 1, 2021 and is designated Class III. Reason for recall: Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality. The recall status is ongoing. Affected quantity: 8,569.
Recall Details
- Product Type
- Devices
- Report Date
- August 11, 2021
- Initiation Date
- July 1, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,569
Product Description
Reason for Recall
Distribution Pattern
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Australia, Brunei Darussalam, Canada, Czech Republic, Denmark, Estonia, Falkland Island (Malvinas), France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Kuwait, Luxembourg, Malaysia, New Zealand, Oman, Papua New Guinea, Philippines, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Arab Emerita, and United Kingdom.