FDAFDA · Food and drugs·Recall number Z-1281-2013
Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
Published May 22, 2013 · Recall initiated: March 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Insight Instruments, Inc.
- Distributor
- US Distribution IN and IL
- Lot
- Lot Numbers: M53157, M55115, M56929, M58551, M61862.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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