STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor
FDA device recall Z-0767-06 · posted 2006-04-18 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Product temperature readings may be 2C higher than the actual temperature
- Action taken
- 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
- Status
- Terminated
- Product code
- FLL
- Quantity affected
- 20,000
- Distribution
- Nationwide, Canada, France, Japan, Netherlands
- Date initiated
- 2006-03-08
- Date posted
- 2006-04-18
- Date terminated
- 2012-05-30
- Location
- Rockland, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T (K864195) | Respiratory Support Products, Inc. | 1986-11-19 |