8mm Tip Cover Accessory

Starting date:

August 8, 2012

Posting date:

September 17, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15553

• Reason
• Affected products

Recalled Products

A. 8mm Tip Cover Accessory

Reason

During the manufacturing process, to package each tip cover, each part is placed into the top open end of a rectangular, pre-made pouch which is sealed along the sides and bottom edges. To seal the pouch containing the product, the open end edge is clamped and sealed by applying heat and pressure, creating a closed seal impressed with a thatched pattern. It has been found, with a small number of the pouches manufactured, when creating the closure the sealed edge was not uniform and pleats or creases were formed within the seal area of the pouch. Of those non-uniform seals, in a small percentage of these seals, these pleats or creases may breach the seal barrier integrity.

Affected products