Ellik Evacuator Glass Body Sterilization Instruction Discrepancy Recall
Olympus recalls Model 190A Ellik Evacuator glass bodies due to discrepancies between sterilization instructions in Japanese and English product materials. Healthcare facilities should verify correct sterilization procedures with the manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where sterilization instruction discrepancies could affect device safety. No illnesses or injuries have been reported. The FDA Class II classification and the safety-critical nature of proper sterilization procedures justify a High severity rating.
Plain-English summary
Olympus Corporation of the Americas is recalling the Glass Body for the Ellik Evacuator (Model Number 190A) due to discrepancies between sterilization instructions provided in the Japanese language product package inserts and those published in the manufacturer's English Instructions For Use (IFU).
The Ellik Evacuator glass body is compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths. Conflicting sterilization instructions between the language versions could result in improper sterilization of the device, potentially affecting patient safety.
Sixteen units have been distributed internationally to Japan. Users of this device should verify the correct sterilization procedures with the manufacturer before continued use.
The recalled product
- Product
- Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Hazard
- labeling-discrepancy
- sterilization-risk
- cross-contamination-risk
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)
- Model Number: 190A. UDI-DI: 00821925003538. All lot numbers
Distribution
Distribution scope not specified by the agency.
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