CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Summary
The FDA issued a Class II for CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)0086000 by CardioQuip, LLC. Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices..
Details
Source
Device Recall
External ID
Z-0035-2022
Action Date
2021-10-13
Status
Ongoing
Category
device
Product Description
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Lot/Code Info: All Serial numbers
Quantity Affected: 1478 units
Reason for Recall
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-12
Company
College Station, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CardioQuip, LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CardioQuip, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CardioQuip, LLC have FDA actions?
CardioQuip, LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0035-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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