Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Warm Air Model 135 Warming Units.

FDA Recall Z-0374-05 · Posted 2004-12-30

Recalling FirmCincinnati Sub-Zero Products
Recall StatusTerminated
Product CodeBTE
Date Initiated2004-11-05
Date Terminated2008-10-29
Product Quantity649 units.

Reason for Recall

Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.

Firm Action

The firm notified consignees by certified letter on November 5, 2004.

Root Cause

Other

Distribution Pattern

The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942599WARM AIR WARMING UNITCincinnati Sub-Zero Products, Inc. · 1995-01-24

Official Source

View FDA Recall →

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

↑