LMA StoneBreaker Intracorporeal Lithotripter System and StoneBreaker System - Pneumatic Lithotripter (2018-03-13)
- Starting date:
- March 13, 2018
- Posting date:
- May 1, 2018
- 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-66640
Affected products
A. LMA StoneBreaker Intracorporeal Lithotripter System - Main Unit
B. StoneBreaker System - Pneumatic Lithotripter
Reason
Product is intended for reprocessing at the user facility. We have identified that the interior of the product may not be sterilized to the appropriate sterility assurance level when following the reprocessing instructions provided in the Instructions for Use.
Affected products
A. LMA StoneBreaker Intracorporeal Lithotripter System - Main Unit
Lot or serial number
All lots.
Model or catalog number
SBA-EC
SBA-EL
SBA-PC
SBA-SC
SBC-10
SBL-KIT1
SBP-010500
SBP-010605
SBP-016500
SBP-016605
SBP-020425
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
46581
UNITED STATES
B. StoneBreaker System - Pneumatic Lithotripter
Lot or serial number
All lots.
Model or catalog number
SBA-EC
SBA-EL
SBA-PC
SBA-SC
SBC-10
SBL-KIT1
SBP-010500
SBP-010605
SBP-016500
SBP-016605
SBP-020425
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
46581
UNITED STATES