Synergetics Recalls 25ga Awh Chandelier Ophthalmic Devices Due to Seal Failure
Synergetics Inc is recalling 36 units of 25ga Awh Chandelier ophthalmic devices 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 injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synergetics Inc is recalling 36 units of 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. The devices are packed 12 units per box and were manufactured for Synergetics, Inc., in O'Fallon, MO.
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 affected lot numbers are M266040 and M269190. The devices were distributed worldwide, including the United States (nationwide) and 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 these devices and contact the manufacturer for instructions.
The recalled product
- Product
- 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. 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: M266040 and M269190
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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