23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactur
FDA device recall Z-0896-2014 · posted 2014-01-30 · Terminated
Recall details
- Recalling firm
- Synergetics Inc
- Reason for recall
- Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- HQB
- Quantity affected
- 26 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, Pakis
- Date initiated
- 2013-12-09
- Date posted
- 2014-01-30
- Date terminated
- 2015-03-25
- Location
- O Fallon, MO
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