The Recall Desk
HighFDA (Devices)·Z-0035-2022·Announced 2021-10-13

CardioQuip Modular Cooler-Heater Devices Recalled for Missing Maintenance Guidance

CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where proper water-quality maintenance is critical for safe operation. The labeling deficiency creates potential for device failure or contamination if users cannot access proper maintenance and inspection guidance. Although no illnesses or injuries have been reported, the absence of critical maintenance information on a Class II medical device poses a significant risk of harm.

Plain-English summary

CardioQuip, LLC is recalling 1,478 units of the CardioQuip Modular Cooler-Heater, Model MCH-1000(i) (CE 2797, UDI: (01)00860000846103), including all serial numbers of this model.

The FDA has classified this as a Class II recall because the device labeling does not include guidance for proper water-quality maintenance and device inspection. These devices are used in medical procedures, and proper maintenance guidance is essential for safe operation.

The affected units have been distributed worldwide, including across the United States (all states and D.C.) and internationally to Germany, The Bahamas, Panama, and Uruguay.

The recalled product

Product
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Manufacturer
CardioQuip, LLC
Category
Medical Device — Surgical Equipment
Hazard
  • missing-maintenance-guidance
  • labeling-deficiency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Serial numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category