Equator Forced Air Convective Warming System, Reference Number EQ 5000
FDA device recall Z-0497-05 · posted 2005-02-03 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 206 units
- Distribution
- Nationwide Foreign: Nederland BV, UK, Finland
- Date initiated
- 2004-12-15
- Date posted
- 2005-02-03
- Date terminated
- 2006-06-27
- Location
- Rockland, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM (K011907) | Sims Level 1, Inc. | 2001-12-18 |