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Terminated

Equator Forced Air Convective Warming System, Reference Number EQ 5000

FDA Recall Z-0497-05 · Posted 2005-02-03

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeDWJ
Date Initiated2004-12-15
Date Terminated2006-06-27
Product Quantity206 units

Reason for Recall

Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Nederland BV, UK, Finland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011907SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEMSims Level 1, Inc. · 2001-12-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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