Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0523-2018 — 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

U.S. FDA — Device Enforcement · United States · 2017-10-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0523-2018
Date of alert: 2017-10-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ecolab, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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