Stamey Needles, Endoscopic Introducer/Extractor, Clarke-Reich laparoscopic Knot Pusher, and Preyra-Raz Ligature Carrier (2017-04-24)

Starting date:

April 24, 2017

Posting date:

May 16, 2017

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-63288

• 
  Reason
• 
  Affected products

Affected Products

A. Stamey Needles

B. Endoscopic Introducer/Extractor

C. Clarke-Reich Laparoscopic Knot Pusher

D. Pereyra-Raz Ligature Carrier

Reason

We have identified that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Our preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet current standards. There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices.

Affected products