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Carpentiers-Edwards PERIMOUNT Magna Ease Valves (2015-01-15)
- Starting date:
- January 15, 2015
- Posting date:
- January 28, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43487
Recalled products
- Carpentiers-Edwards PERIMOUNT Magna Ease Valves
Reason
The jar and box labels on specified serial numbers of this valve indicate an incorrect valve size of 23mm. The size indicated on the identification tag attached to the valve (25mm) is correct, and all other information provided on the labels (model number, serial number, expiration date) is correct.
Affected products
A. Carpentiers-Edwards PERIMOUNT Magna Ease Valves
Lot or serial number
- 4190338
- 4190339
- 4190340
- 4190341
- 4190343
- 4190344
- 4190345
- 4190346
- 4190347
- 4190349
Model or catalog number
- 3000TFX23
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES