Cardiac Insulation Pad recalled over sterility concerns

Recall date

April 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medline Industries, Inc. recalls Cardiac Insulation Pad, OPEN HEART CDS

Recall number

Z-2979-2018

FDA classification

Class II

Brand / firm

Medline Industries, Inc.

Sold / distributed

CA, NM

Why it was recalled

Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiac Insulation Pad, OPEN HEART CDS