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Health product recall

INTUITIVE SURGICAL DEVICES (2015-08-25)

Starting date:
August 25, 2015
Posting date:
September 29, 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-55098

Recalled Products

  1. Maryland Dissector
  2. Single Site Crocodile Grasper
  3. Single Site Medium - Large Clip Applier
  4. Single-set Needle Driver

Reason

Under rare circumstances, grip-actuated instruments may become fixed in a closed position.

Affected products

A. Maryland Dissector

Lot or serial number

All lots.

Model or catalog number

Not applicable

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101,
Sunnyvale
94086
California
UNITED STATES

B. Single Site Crocodile Grasper

Lot or serial number

All lots.

Model or catalog number

Not applicable

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101,
Sunnyvale
94086
California
UNITED STATES

C. Single Site Medium - Large Clip Applier

Lot or serial number

All lots.

Model or catalog number

Not applicable

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101,
Sunnyvale
94086
California
UNITED STATES

D. Single-set Needle Driver

Lot or serial number

All lots.

Model or catalog number

Not applicable

Companies
Manufacturer
Intuitive Surgical
1266 Kifer Road, Building 101,
Sunnyvale
94086
California
UNITED STATES