Medilas D Laser System - Optical Fiber, Laser Fiber Light Guides (2019-04-27)
- Starting date:
- April 27, 2019
- Posting date:
- June 14, 2019
- 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-70189
Last updated: 2019-06-14
Affected Products
A. Medilas D Laser System - Optical Fiber
B. Laser Fiber Light Guides
Reason
During a routine re-evaluation of the packaging design for the diode fibers conducted to confirm a 5 year shelf life, test results indicated that the current package design, paper/poly pouch, showed pin hole package failures indicating that the packaging design is highly vulnerable to mechanical stress, leading to it not meeting the specified shelf-life of five years.
Affected products
A. Medilas D Laser System - Optical Fiber
Lot or serial number
All lots.
Model or catalog number
K1008084
Companies
- Manufacturer
-
DORNIER MEDTECH AMERICA, INC.
1155 ROBERTS BLVD.
KENNESAW
30144
Georgia
UNITED STATES
B. Laser Fiber Light Guides
Lot or serial number
All lots.
Model or catalog number
K1001292
K1001293
K2012393
K2012875
Companies
- Manufacturer
-
DORNIER MEDTECH AMERICA, INC.
1155 ROBERTS BLVD.
KENNESAW
30144
Georgia
UNITED STATES