Synergetics Recalls Vivid Endo Illuminator Due to Faulty Seals
Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a seal failure could compromise sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Synergetics Inc. is recalling the Wide Field Endo Illuminator, Vivid Endo Illuminator, 20ga, sterile/EO, 56.21P. The recall affects units packed 12 per box, manufactured for Synergetics, Inc., in O'Fallon, MO.
The recall was initiated because faulty seals on the outer pouch of these double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. This defect poses a risk to the sterility of the medical device.
The affected lot number is M264060. The product was distributed worldwide, including the United States (nationwide) and the following countries: 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. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: M264060
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Synergetics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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