Integra CUSA Dissectron Fingertip Laparoscopic Cannula Recalled for Packaging Seal Defect
Integra LifeSciences is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas due to incomplete sterile packaging seals discovered during final inspection.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging defect that compromises sterility, which fits the criteria for a moderate risk where the defect is identified before widespread use or harm.
Plain-English summary
Integra LifeSciences Corp. is recalling 9 units of CUSA Dissectron Fingertip Laparoscopic Cannulas, REF F75221. The affected units are sterile, ethylene oxide (EO) sterilized, and packaged in Tyvek pouches within cardboard boxes. The specific lot number is 0195486 with an expiration date of 04/2021.
The recall was initiated after final sampling inspection revealed that one of the lots had a total incomplete packaging seal on the sterile product. This defect compromises the sterile barrier of the device. The distribution was limited to Kansas (KS) only.
Healthcare providers and facilities that have received these specific units should stop using them immediately and contact the manufacturer for instructions on return or disposal. Patients who have already received treatment with these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 9
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 (2)
- Catalog Number F75221
- Lot #0195486 with expiry 04/2021
Distribution
Part of a larger recall action
This product is one of 6 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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