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Phasix Mesh
- Starting date:
- July 10, 2017
- Posting date:
- August 14, 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-64124
Reason
Davol Inc. has identified certain product code / lot number combinations of Phasix mesh that contain instructions for use (IFU) with indications other than those licensed by Health Canada. The minor variation in the product information has no effect on the safety and efficacy of the product.
Affected products
Phasix Mesh
Lot or serial number
- HUAY1592
- HUAY1594
- HUAZ0047
- HUAZ0049
Model or catalog number
- 1190300
- 1190400
- 1190500
Companies
- Manufacturer
-
Davol, Inc., Subsidiary of C.R. Bard Inc.
100 CROSSINGS BLVD.
Warwick
02886
Rhode Island
UNITED STATES