Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a documentation error (incorrect drying time in the manual) that could lead to incomplete drying, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) and the associated Norwegian OPS Manual (P/N 60905788). The product was distributed in the United States and internationally.
The recall was initiated because the 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 discrepancy could result in incomplete drying of the components.
Healthcare facilities and users of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System should stop using the affected sterilization trays and manuals. They should contact Integra LifeSciences Corp. for instructions on how to proceed with the recall and obtain corrected documentation.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Norwegian OPS Manual P/N 60905788
Distribution
Part of a larger recall action
This product is one of 42 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · incomplete drying
See all →- ModerateIntegra C7000 CUSA Clarity System Recalled for Drying Time Error
FDA (Devices) · 2019-12-18
- ModerateIntegra C7000 CUSA Clarity System Recall for Drying Time Discrepancy
FDA (Devices) · 2019-12-18
- ModerateIntegra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying
FDA (Devices) · 2019-12-18
- ModerateIntegra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time
FDA (Devices) · 2019-12-18