Recall Z-1395-2016 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
| Date | Mar 4, 2016 |
| Status | Terminated |
| Reason | Complaints were received of restricted/inaccurate flow rate. |
| Root cause | Process control |
| Action | Bard Medical sent an Urgent Medical Product Recall letter dated March 4, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to not use any of the affected products and to return any unused product Bard Medical Division via the provided Customer Recall and Effectiveness Form. BMD will be providing a replacement for the returned product. If the product was further distributed, the consignee was instructed to identify their customers and notify them of the product recall. |
| Quantity | 21,412 units |
| Distribution | Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, K |
| 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 |