Z-0038-2022 Class II Ongoing
FDA device recall Z-0038-2022 was initiated by CardioQuip, LLC on May 12, 2021 and is designated Class II. Reason for recall: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. The recall status is ongoing. Affected quantity: 369 uniyd.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- May 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 369 uniyd
Product Description
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Reason for Recall
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.
Code Information
All Serial numbers