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Terminated

TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor

FDA Recall Z-0768-06 · Posted 2006-04-18

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFLL
Date Initiated2006-03-08
Date Terminated2012-05-30
Product Quantity400

Reason for Recall

Product temperature readings may be 2C higher than the actual temperature

Firm Action

Smiths Medical notified consignees by letter dated 3/8/05. Customers are instructed to complete customer reply notices and return affected products for replacement.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, France, Japan, Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864195SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE TRespiratory Support Products, Inc. · 1986-11-19

Official Source

View FDA Recall →

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

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