Z-0879-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2014
- Initiation Date
- December 9, 2013
- Termination Date
- March 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. 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.
Distribution Pattern
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.
Code Information
Lot number: M266040 and M269190