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Tri-Ex Extraction Balloon with Multiple Sizing (2014-07-14)
- Starting date:
- July 14, 2014
- Posting date:
- August 8, 2014
- 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-40825
Recalled products
- Tri-Ex Extraction Balloon with Multiple Sizing
Reason
Some units of the recalled device may not fit down a 2.8mm endoscope despite being labeled as compatible with endoscope channels of that size. The issue was uncovered during a customer complaint investigation.
Affected products
A. Tri-Ex Extraction Balloon with Multiple Sizing
Lot or serial number
- W3342312
Model or catalog number
- TXR-ME
Companies
- Manufacturer
-
Wilson Cook Medical Inc.
4900 Bethania Station Rd.
Winston Salem
27105
North Carolina
UNITED STATES