This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
LigaSure Blunt Tip Laparascopic and Impact Open Sealer/Divider (2016-11-22)
- Starting date:
- November 22, 2016
- Posting date:
- December 13, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-61422
Affected Products
- LigaSure Blunt Tip Laparoscopic Sealer/Divider
- LigaSure Impact Open Sealer/Divider
Reason
Manufacturer has received complaints reporting that reprocessed LF1637 or LF4318 Ligasures experienced compatibility issues when connected to the FT10 generator. An "invalid instrument" error message may appear on FT10 generators with software revision 1.1.5.4 when devices without a radio-frequency identification (RFID) chip are connected to the generator. Updates were made to the instructions for use (IFU) to provide clarity on software compatibility.
Affected products
A. LigaSure Blunt Tip Laparoscopic Sealer/Divider
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LF1637
Companies
- Manufacturer
-
STRYKER SUSTAINABILITY SOLUTIONS
1810 West Drake Dr.
Tempe
85283
UNITED STATES
B. LigaSure Impact Open Sealer/Divider
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LF4318
Companies
- Manufacturer
-
STRYKER SUSTAINABILITY SOLUTIONS
1810 West Drake Dr.
Tempe
85283
UNITED STATES