Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual incorrectly states a 30-minute drying cycle, whereas 40 minutes are required for complete drying.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a documentation error regarding drying time, which fits the rubric for moderate severity involving low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is triggered by a documentation error in the Spanish Operators Manual (P/N 60905199). The manual currently lists a minimum dry time of 30 minutes for the 36 kHz Sterilization Tray and 36 kHz Components, but the system actually requires 40 minutes for complete drying.
The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers should verify the drying time requirements for the 36 kHz Sterilization Tray and ensure that the 40-minute cycle is used to meet Dry Time Criteria. Users should refer to the updated documentation provided by the manufacturer to ensure proper sterilization procedures.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 820
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)
- Spanish OPS Manual P/N 60905199
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.
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