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

Recalled February 14, 2018 · FDA recall Z-0523-2018 · Ecolab

Hazard

Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. · FDA Class II

Units

5,958 cases (50 per case)

Sold at

Distributed domestically to Michigan.

Description

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

Product

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.

Manufacturer(s)

Ecolab, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →