Ellik Evacuator Tubing Recalled Due to Sterilization Instruction Discrepancies
Olympus is recalling tubing for the Ellik Evacuator due to discrepancies between sterilization instructions in Japanese language package inserts and the manufacturer's Instructions for Use.
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 an FDA Class II recall involving sterilization instruction discrepancies that present a risk of improper equipment sterilization. Per the rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling the Tubing for Male Connector 194 used with the Ellik Evacuator (Model Number 190-4). This tubing is compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
The recall addresses discrepancies between sterilization instructions in the Japanese language product package inserts and those in the manufacturer's Instructions for Use (IFU). These differences could potentially lead to confusion about proper sterilization procedures and improper device sterilization.
The affected product was distributed internationally to Japan, and all lot numbers of Model 190-4 are included in this recall.
Users should ensure they understand and follow the correct sterilization instructions before use to maintain proper device safety and function.
The recalled product
- Product
- Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- sterilization-instruction-discrepancy
- labeling-error
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: 190-4. UDI-DI: 00821925003491. All lot numbers
Distribution
Distribution scope not specified by the agency.
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