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Open, Classified

Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

FDA Recall Z-0590-2018 · Posted None

Recalling FirmC.R. Bard, Inc.
Recall StatusOpen, Classified
Product CodeDWJ
Date Initiated2017-06-02
Product Quantity128 units

Reason for Recall

Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.

Firm Action

Customers were notified on approximately 06/02/2017 via FedEx with delivery confirmation and per the individual country's delivery system. Instructions included to examine inventory and identify any product subject to the recall and notify customers if product was further distributed. If customers wished to return product, they were instructed to contact customer service at 1-800-526-4455.

Root Cause

Labeling mix-ups

Distribution Pattern

Distributed domestically. Distributed internationally to Australia and Belgium.

Official Source

View FDA Recall →

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

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