25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
This recall has been terminated (originally issued January 30, 2014).
- Company
- Synergetics Inc
- Recall Initiated
- December 9, 2013
- Posted
- January 30, 2014
- Terminated
- March 25, 2015
- Recall Number
- Z-0880-2014
- Quantity
- 108 Units
- Firm Location
- O Fallon, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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.
Lot / Code Info
Lot number: M261810
Root Cause
Use error
Action Taken
Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.