Grace Hysterectomy Pack and Ensemble Prothese De Genou (2016-03-16)

Starting date:

March 16, 2016

Posting date:

January 8, 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-65604

• 
  Reason
• 
  Affected products

Affected Products

A. Grace Hysterectomy Pack

B. Ensemble Prothese De Genou

Reason

These packs contain laparotomy sponges that have been recalled by Medtronic (Covidien Curity, Curity X-Ray, Kerlix X-Ray, Vistec X-Ray). Medtronic states that the seal integrity of the lap sponge package may be compromised resulting in potential breach of the sterile barrier. This could lead to an increased risk of infection. Medtronic reports no adverse incidents associated with this issue. Medline Canada has not received any complaints of this nature.

Affected products