FDA Medical Device Recalls (openFDA)
CardioQuip, LLC: CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
- Recall number
- Z-0565-2024
- Recalling firm
- CardioQuip, LLC
- Product
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
- Status
- Open, Classified
- Initiated
- 2023-10-24
- Posted
- 2023-12-15
- Terminated
- not on file
- Reason
- There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- Root cause
- Process control
- Action
- On October 24, 2023, CardioQuip issued a "Urgent: Medical Device Correction/Removal" notification via USPS to all affected consignees. CardioQuip ask consignees to take the following actions: 1. CardioQuip recommends that you remove your potentially contaminated MCH device from service immediately. 2. CardioQuip Customer Service will contact you by November 3, 2023 to provide your facility with a loaner device and to schedule an IWPR procedure for your MCH device. 3. Please complete and return the Receipt of Communication/Response Form attached to this letter to CardioQuip as soon as possible. 4. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program:
- Quantity
- 4 units
- Distribution
- US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
- Lot, serial or model codes
- UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
- 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