"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Reported: February 5, 2014 Initiated: December 9, 2013 #Z-0888-2014
Product Description
"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. 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.
Details
- Recalling Firm
- Synergetics Inc
- Units Affected
- 12 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, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
- Location
- O Fallon, MO
Frequently Asked Questions
What product was recalled? ▼
"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.. Recalled by Synergetics Inc. Units affected: 12 units.
Why was this product recalled? ▼
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0888-2014.
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