Z-0036-2022 Class II Ongoing
FDA device recall Z-0036-2022 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: 1380 units.
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
- 1380 units
Product Description
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
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