Gyrus ACMI Falope-Ring Dilator (2014-07-09)

Starting date:

July 9, 2014

Posting date:

July 25, 2014

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-40727

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  Reason
• 
  Affected products

Gyrus ACMI Falope-Ring Dilator

Reason

On April 4, 2014 a communication from the OSTA US distributor drew attention to the fact that part 000878-4, Falope-Ring Dilator was inadvertently made available through the order system to customers and OSTA was shipping this item to our distributors in a non-sterile state. This item is normally only intended for use as a component provided with the Falope ring band FRB- 30 kits. The FRB-30 kits, including this component, are sold sterile. This item is a dilator intended to assist placement of the Falope band on the applicator. It contacts the sterile Falope ring band as the band is loaded onto a reusable applicator, and just prior to the band's implantation in the patient. As such, it must be sterile in order to avoid the possibility of contaminating the Falope ring band prior to use. No complaints related to these items have been received.

Affected products