Date Initiated by Firm | June 02, 2017 |
Create Date | February 12, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0590-2018 |
Recall Event ID |
77469 |
510(K)Number | K142702 |
Product Classification |
System, thermal regulating - Product Code DWJ
|
Product | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 |
Code Information |
Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021. |
Recalling Firm/ Manufacturer |
C.R. Bard, Inc. 8195 Industrial Blvd NE Covington GA 30014-1497
|
For Additional Information Contact | 800-526-4455 |
Manufacturer 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. |
FDA Determined Cause 2 | Labeling mix-ups |
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. |
Quantity in Commerce | 128 units |
Distribution | Distributed domestically.
Distributed internationally to Australia and Belgium. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = DWJ
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