Devon Kits (2016-09-29)

Starting date:

September 29, 2016

Posting date:

November 25, 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-61200

• Reason
• Affected products

Affected Products

• A. Devon Birthday Kit C-Section Basic
• B. Devon Light Glove
• C. Devon OR Mini Kit

Reason

Customers have reported that on rare occasion, the Devon Light Glove may split upon application to the Devon Light Handle Adapter. A subset of these splits reportedly resulted from a difficult application of the glove to the handle adapter. A split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter.

Affected products