Challenger Ligature and Marking Clips, DS Clip Appliers (2018-01-16)
- Starting date:
- January 16, 2018
- Posting date:
- January 29, 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-65820
Affected products
- Challenger Ligature and Marking Clips
- DS Clip Appliers
Reason
During review of the IFU, it was detected additional missing contraindications, and reprocessing instructions also required revision. There is no clinical data linked to the usage of the DS Clips for the closure of the renal artery or renal vein during nephrectomies in living donor patients, Aesculap wants to avoid any potential patient risk by including this and other contraindications and also revising the cleaning and sterilization instructions.
Affected products
A. Challenger Ligature and Marking Clips
Lot or serial number
Not applicable
Model or catalog number
- PL459SU
- PL462SU
- PL465SU
Companies
- Manufacturer
-
Aesculap AG
Am Aesculap-Platz
Tuttlingen
78532
GERMANY
B. DS Clip Appliers
Lot or serial number
Not applicable
Model or catalog number
- PL806R
- PL817R
Companies
- Manufacturer
-
Aesculap AG
Am Aesculap-Platz
Tuttlingen
78532
GERMANY