Device product
Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Z-0874-2014
Product summary
- Firm
- Synergetics Inc
- Event
- Event 67147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 units
- Official record key
device-enforcement:Z-0874-2014
Official wording
Reason: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Code information: Lot numbers: M258430 and M265950
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.
Derived failure modes
-
Sterility assurance
sterile, ophthalmic devices could result in seal failure