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Esophageal Cooling Device / Ensoetm
- Starting date:
- August 3, 2017
- Posting date:
- September 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64422
Reason
One lot of catalog # ECD02-B medical devices distributed in Canada (Lot # 199136216A) may contain a significant percentage of devices with an excessive amount of adhesive in one of the bonded joints. The excessive adhesive may significantly restrict or prevent fluid flow through the device. This issue can be immediately recognized by the end user, as the external console has a low flow alarm that will indicate to the user that fluid is not properly flowing through the device upon connection of the device and initiation of fluid flow.
Affected products
Esophageal Cooling Device / Ensoetm
Lot or serial number
199136216A
Model or catalog number
ECD02-B
Companies
- Manufacturer
-
Attune Medical
3440 S. Dearborn St., #215-South
Chicago
60616
Illinois
UNITED STATES