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Ventralight ST Mesh with Echo - Ellipse and Echo (2014-04-29)
- Starting date:
- April 29, 2014
- Posting date:
- May 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-39401
Recalled Products
A. Ventralight ST Mesh with Echo - Ellipse
B. Ventralight ST Mesh with Echo - Oval
Reason
There have been two customer complaints of an unsealed pouch for the included, separately packaged, sterile inflation assembly and inflation adapter. These components are used together to inflate the Ventralight ST mesh with Echo PS positioning system balloon, external to the patient, but within the sterile field.
Affected products
A. Ventralight ST Mesh with Echo - Ellipse
Lot or serial number
HUXH0691
HUXK0899
HUXL0660
Model or catalog number
5955790
5955810
Companies
- Manufacturer
-
Davol Inc., Subsidiary of C.R. Bard Inc.
100 Crossings Blvd.
Warwick
02886
Rhode Island
UNITED STATES
B. Ventralight ST Mesh with Echo - Oval
Lot or serial number
HUXL1004
Model or catalog number
5955610
Companies
- Manufacturer
-
Davol Inc., Subsidiary of C.R. Bard Inc.
100 Crossings Blvd.
Warwick
02886
Rhode Island
UNITED STATES