Recall Z-1679-2014 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
| Date | Jun 10, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but |
| Root cause | Mixed-up of materials/components |
| Action | The firm initiated a telephone notification on 01/08/2014, followed by a written notification which was sent to the customers via letter or email on 01/31/2014. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed respo |
| Quantity | 7 units |
| Distribution | The product was distributed to one customer in MI, and internationally (Taiwan) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM Cincinnati Sub-Zero Products, Inc., Feb 4, 2011 |