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

Recall Z-1088-2021 — Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minim

U.S. FDA — Device Enforcement · United States · 2021-01-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1088-2021
Date of alert: 2021-01-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardinal Health 200, LLC
Product category: device
Product type: Devices

Reported risk: There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

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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