Z-0884-2014 Class II Terminated
FDA device recall Z-0884-2014 was initiated by Synergetics Inc on December 9, 2013 and is designated Class II. Reason for recall: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. The recall status is terminated (terminated March 25, 2015). Affected quantity: 102 Units.
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
- 102 Units
Product Description
23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P 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 numbers: M257130 and M265370