FDAClass IIFebruary 5, 2014

23ga Wide Field Endo Illuminator recall

23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics…

Why was 23ga Wide Field Endo Illuminator recalled?

Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: M261310, M262650, M263630, M265960, and M268970

Product
23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics…
Recalling firm
Synergetics Inc
Quantity
568 units
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.
Recall date
February 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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