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.
Reported: February 14, 2018 Initiated: October 13, 2017 #Z-0523-2018
Product Description
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.
Reason for Recall
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Details
- Recalling Firm
- Ecolab, Inc.
- Units Affected
- 5,958 cases (50 per case)
- Distribution
- Distributed domestically to Michigan.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product 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.. Recalled by Ecolab, Inc.. Units affected: 5,958 cases (50 per case).
Why was this product recalled? ▼
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0523-2018.
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