Recall Z-0523-2018— Ecolab, Inc.
Class II · Terminated
Class II FDA medical device recall by Ecolab, Inc., initiated 2017-10-13, terminated 2020-07-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch..
- Recalling firm
- Ecolab, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-13
- Terminated
- 2020-07-22
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.