Olympus Corporation of the Americas: Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Hazard

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

Details from the source

Reason for recall: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America. Quantity: 3,241 units Lot/code info: Model Number: 194. UDI-DI: 0082192500586. All Lot Numbers.

UPC codes

0082192500586

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.