Cataract and Cornea Packs (2017-11-22)

Starting date:

November 22, 2017

Posting date:

December 8, 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, Hospitals, Healthcare Professionals

Identification number:

RA-65342

• Reason
• Affected products

Affected products

A. CATARACT PACK
B. Cornea Packs

Reason

Cardinal Health has been informed by Beaver-Visitec of a field safety notice for the Beaver Xstar Safety Knives (contained in the cardinal health kits). The knives feature an integrated retractable safety shield to minimize the risk of accidental surgical blade injuries during handling. Beaver-Visitec has received 20 complaints in which the protective shield was retracted, thereby exposing the blade. The knives are provided in a Tyvek covered tray and customers are advised prior to opening the Tyvek tray, to visually confirm that the plastic shield is not retracted. If the shield is in the retracted position, the knife remains fully functional for its intended use.

Affected products