Synergetics Recalls Corona Shielded Wide Field Endo Illuminator Due to Seal Failure
Synergetics Inc. is recalling specific lots of Corona Shielded Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.
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 seal failure could compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Synergetics Inc. is recalling the "The Corona" Shielded Wide Field Endo Illuminator, a sterile, single-use ophthalmic device. The recall affects units packed 12 per box, manufactured in O'Fallon, MO, and distributed worldwide, including the United States and numerous international markets.
The recall is due to faulty seals on the outer pouch of the double-pouched, single-use devices. This defect could result in seal failure, which may compromise the sterile status of the device. The specific lot number identified in the recall is M266740.
Healthcare providers and facilities should stop using the affected devices and contact Synergetics Inc. for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- "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.
- 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: M266740
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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