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Terminated

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.

FDA Recall Z-0523-2018 · Posted None

Recalling FirmEcolab, Inc.
Recall StatusTerminated
Product CodeFTA
Date Initiated2017-10-13
Date Terminated2020-07-22
Product Quantity5,958 cases (50 per case)

Reason for Recall

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

Firm Action

Ecolab sent and Urgent Medical Device Recall letter dated October 13, 2017 to customers. The identified the affected product, problem and actions to be taken. Instructions include to immediately quarantine lots in inventory, notify customers since the product has been further distributed, return affected product, and complete and return the Recall Response Form. For questions call 903-597-2568.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed domestically to Michigan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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