Corflo-Max PEG Kit Pull (2020-03-19)

Starting date:

March 19, 2020

Posting date:

April 17, 2020

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-72803

Last updated: 2020-04-17

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  Reason
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  Affected products

Affected Products

Corflo-Max PEG Kit Pull

Reason

Avanos Medical (formerly Halyard Health) has received 3 complaint reports stating that the Corflo* PEG tube may be blocked at the center of the adapter (occluded). Avanos reviewed its inventory and demonstrated the defect rates to be 1.4% for full occlusion and 2.2% for partial occlusion, based on lots produced after the implementation of the suspected root cause. A PEG tube that is occluded may not be functional and the PEG procedure may be delayed or aborted. A new PEG tube placement may be required to continue with the procedure. There is no need for concern in patients who have had PEGs placed that function normally, which are de facto unoccluded.

Affected products