Various Cardinal Health Sterile Packs (2016-11-02)

Starting date:

November 2, 2016

Posting date:

November 18, 2016

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-61148

• 
  Reason
• 
  Affected products

Affected Products

1. Sterile Breast Pack
2. Sterile Cardiac Pack
3. Sterile Abdominal Pack
4. Sterile Extremity Pack
5. Sterile Strabismus Pack
6. Sterile Dental Pack

Reason

Cardinal Health has been informed by Medtronic of a medical device correction in regards to Covidien Devon Light Gloves contained in presource kits.  This correction has been initiated to update labeling of the instructions for use. Medtronic advises that on rare occasion, the Devon Light Glove may split upon application to the Devon Light Handle Adapter. A split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. The following statement will be added to the instructions for use to help staff ensure that the sterile field is maintained: "after application, inspect the light glove for barrier integrity".

Affected products