Health product recall

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

  1. Challenger Ligature and Marking Clips
  2. 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