Recall Z-0036-2022
CardioQuip, LLC · initiated May 12, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Codes / lots: All Serial numbers
Reason for recall
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
FDA-determined cause: Error in labeling
Action taken
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 sterile or 0.22-micron-filtered water. Do not use tap water to rinse, fill, refill, or top-off watertanks, as this may introduce microorganisms into the water path. 3.When making ice needed for patient cooling during surgical procedures, use only sterile or 0.22-micron-filtered water. 4. Strictly adhere to the maintenance activities of cleaning and disinfection found on pg. 47-51 of the newMCH Operator/Service Manual R3 2021. 5.Schedule annual preventive maintenance by an authorized CardioQuip technician as outlined on pg.51 of the new MCH Operator/Service Manual R3 2021. 6.Clean and disinfect all accessories connected to the cooler-heater according to the respective manufacturer s instructions for use. Device contamination can occur from sources such as environmental contamination or device contact with contaminated accessories. 7.Ensure all modules and accessories, including the Refrigeration Module and TEC lid, are cleaned and disinfected at the same time as the MCH unit according to the Maintenance section of the new MCH Operator/Service Manual R3 2021. 8.Do NOT move modules or accessories between cooler-heater devices to prevent possible cross-contamination. 9.Immediately remove from service devices that show signs of contamination in the tank or water path, such as cloudiness or discoloration. Contact CardioQuip Customer Service to receive assistance with contamina
Details
- Recall number
- Z-0036-2022
- Initiated
- May 12, 2021
- Posted by FDA
- October 6, 2021
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 1380 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, The Bahamas, Panama, Uruguay.
- Recalling firm
- CardioQuip, LLC, College Station, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0035-2022 Class II | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |
| Z-0037-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI:…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |
| Z-0038-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model:…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | 05/12/2021Open, Classified |