PlainRecalls
FDA Devices Moderate Class II Terminated

Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

Reported: February 5, 2014 Initiated: December 9, 2013 #Z-0892-2014

Product Description

Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

Reason for Recall

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

Details

Recalling Firm
Synergetics Inc
Units Affected
48 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.
Location
O Fallon, MO

Frequently Asked Questions

What product was recalled?
Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.. Recalled by Synergetics Inc. Units affected: 48 units.
Why was this product recalled?
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0892-2014.