Recall Z-0497-05 ยท DWJ System, Thermal Regulating
Smiths Medical ASD, Inc.
Equator Forced Air Convective Warming System, Reference Number EQ 5000
| Date | Feb 3, 2005 (initiated Dec 15, 2004) |
| Status | Terminated |
| Reason | Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt |
| Root cause | Other |
| Action | Smiths Medical ASD notified customers by letter issued Fed''X on 12/15/04. Accounts are requested not to use the device and return the unit if the the unit has not yet been placed into service. If the unit has been placed into service and operated for more than one hour then the problem will not occur. EQ-5000 unit(s) will be replaced. |
| Quantity | 206 units |
| Distribution | Nationwide Foreign: Nederland BV, UK, Finland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011907 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM Sims Level 1, Inc., Dec 18, 2001 |