FDA Medical Device Recalls (openFDA)
CardioQuip, LLC: CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
- Recall number
- Z-0035-2022
- Recalling firm
- CardioQuip, LLC
- Product
- CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
- Status
- Open, Classified
- Initiated
- 2021-05-12
- Posted
- 2021-10-06
- Terminated
- not on file
- 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 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
- 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, The Bahamas, Panama, Uruguay.
- Lot, serial or model codes
- All Serial numbers
- 510(k) numbers
- ["K102147"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 3007899424
- Firm city
- College Station
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28