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Irrigation Set
- Starting date:
- July 1, 2016
- Posting date:
- March 16, 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-62654
Reason
Omnia has determined that during the assembling phase, if tightening rings are not perfectly placed, it is possible that in a condition of maximum flow and pressure the tube can detach causing leakage of saline solution.
Affected products
Irrigation Set
Lot or serial number
15040308
15042402
15111204
Model or catalog number
32.F0134.00
Companies
- Manufacturer
-
Omnia Spa
Via Francesco Delnevo 190sx
Fidenza PR
43036
ITALY