FDA-Device2018-02-14Class II
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.
Ecolab, Inc.
Hazard
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Sold states
Distributed domestically to Michigan.
Affected count
5,958 cases (50 per case)
Manufactured in
940 Lone Oak Rd, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2018Don't want to check this manually?
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