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

Recall Z-2160-2012 — The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a

U.S. FDA — Device Enforcement · United States · 2012-02-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2160-2012
Date of alert: 2012-02-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Afassco Inc
Product category: device
Product type: Devices

Reported risk: The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because product lacked the warning label: "CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions."

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

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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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