Laparoscopy CDS 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 Laparoscopy CDS

Recall number

Z-2978-2018

FDA classification

Class II

Brand / firm

Medline Industries, Inc.

Sold / distributed

CA, NM

Why it was recalled

One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.

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

What was recalled

Laparoscopy CDS