U.S. FDA — Device Enforcement · United States · 2013-12-09 · Class II
As described by U.S. FDA — Device Enforcement: 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
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.
Reported risk: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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