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Suction House Irrigator (2015-03-06)
- Starting date:
- March 6, 2015
- Posting date:
- April 29, 2015
- 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-53117
Recalled products
- Suction House Irrigator
Reason
House suction irrigators lots were mis-etched with "4 FR" on the fingerplate. The label on the shelf pouch indicates "2.5 FR" and the actual product meets the physical dimensions of a 2.5 FR product but the products themselves are etched as"4 FR" on the fingerplate.
Affected products
A. Suction House Irrigator
Lot or serial number
- 140601
- 140602
Model or catalog number
- 3724217
Companies
- Manufacturer
-
Medtronic Xomed Inc.
6743 Southpoint Drive North
Jacksonville
Florida
UNITED STATES