Recall Z-0035-2022 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
CardioQuip, LLC
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
| Date | Oct 6, 2021 (initiated May 12, 2021) |
| Status | Open, Classified |
| Reason | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| Root cause | Error in labeling |
| Action | On 7/30/21, CardioQuip issued a "Urgent Medical Device Correction" notification to all affected consignees. The communication was provided via US Mail, E-Mail and firm's website. In addition, to informing consignees about the correction, CardioQuipe ask consignees to take the following actions: 1.Replace copies of the current MCH Operators/Service Manual R2 2016 with the updated version MCHOperators/Service Manual R3 2021 provided as of July 30, 2021 on our website: http://www.CardioQuip.com/resources. This new version includes revisions that reflect the content in this letter. 2.Only use |
| Quantity | 1478 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 Cardioquip Llp, Nov 19, 2010 |