Reported Dec 18, 2019 · Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Lot codes and dates
- French OPS Manual P/N 60905770
- Amount recalled
- 820
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Where it was sold
Why it was recalled
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
This product could cause temporary or reversible health problems — stop using it.
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