ClearanceBrief
Recall Z-0374-05 ยท BTE

Cincinnati Sub-Zero Products

Warm Air Model 135 Warming Units.

DateDec 30, 2004 (initiated Nov 5, 2004)
StatusTerminated
ReasonBurning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.
Root causeOther
ActionThe firm notified consignees by certified letter on November 5, 2004.
Quantity649 units.
DistributionThe product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K942599WARM AIR WARMING UNIT
Cincinnati Sub-Zero Products, Inc., Jan 24, 1995