Recall Z-0590-2018 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
| Date | Jun 2, 2017 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 | 128 units |
| Distribution | Distributed domestically. Distributed internationally to Australia and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad Medivance, Inc., Dec 18, 2014 |