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CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE… recallZ-0035-2022 · CardioQuip, LLC · initiated May 12, 2021

Class II Open, Classified All recalls posted in October 2021

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CardioQuip, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

FDA root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-0035-2022
Recall class
Class II
Status
Open, Classified
Initiated by the company
May 12, 2021
Posted by the FDA
Oct 6, 2021
Recalling firm
CardioQuip, LLC
Quantity
1478 units
Product code
DWC
FDA submissions
K102147
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.

Product description

CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Code information (models, lots, serial numbers)

All Serial numbers

Other devices under the same FDA submission

2 devices cleared under K102147 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88622).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page