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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