Ecolab, Inc. recalls Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches…

Recall date

October 13, 2017

Source

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

Recall number

Z-0523-2018

FDA classification

Class II

Brand / firm

Ecolab, Inc.

Sold / distributed

Distributed domestically to Michigan.

Why it was recalled

Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

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

What was recalled

Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.