Recall Z-2345-2016 ยท DWJ System, Thermal Regulating
C.R. Bard, Inc.
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
| Date | Aug 5, 2016 (initiated Jun 30, 2016) |
| Status | Terminated |
| Reason | An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected. |
| Root cause | Other |
| Action | A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned. If you have any further questions please call (401) 825-8690. |
| Quantity | 64 |
| Distribution | US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland |
| 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 |