Synergetics Recalls 25ga Awh Chandelier Due to Faulty Sterile Seals
Synergetics Inc. is recalling 36 units of 25ga Awh Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.
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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used in ophthalmic procedures, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synergetics Inc. is recalling 36 units of 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. The devices are packed 12 units per box and were manufactured for Synergetics, Inc., in O'Fallon, MO. The specific lot number is M269200.
The recall is due to faulty seals on the outer pouch of these double-pouched, single-use, sterile, ophthalmic devices. This defect could result in seal failure, which may compromise the sterile integrity of the product. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in 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 Synergetics Inc. for instructions on return or replacement.
The recalled product
- Product
- 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 36
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: M269200
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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