Ellik Evacuator non-locking cone has conflicting sterilization instructions in Japan
The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
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: FDA Class II recall for a documentation discrepancy between two sets of instructions, with no device defect or clinical consequence stated.
Plain-English summary
The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model number 191-NRS, UDI-DI 00821925003545, is being recalled across all lot numbers. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths. The action covers 2 units.
The stated reason is discrepancies between the sterilization instructions in the Japanese language product package inserts and those published in the manufacturer's product Instructions For Use. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was international, to Japan.
Facilities should identify affected stock using the model number and UDI-DI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 2
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: 191-NRS. UDI-DI: 00821925003545. All lot numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by Olympus Corporation of the Americas 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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