FDAFDA · Food and drugs·Recall number Z-0885-2014
25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Published February 5, 2014 · Recall initiated: December 9, 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
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synergetics Inc
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
- Lot
- Lot numbers: M260010 and M275520
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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