Synergetics Recalls 27ga Ophthalmic Chandelier Due to Faulty Sterile Seals
Synergetics is recalling 24 units of 27ga ONE-STEP Awh/Tano Vivid Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Synergetics Inc. is recalling 24 units of the 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, a sterile, single-use ophthalmic device. The product is manufactured in O'Fallon, Missouri, and is packed 12 units per box. The specific lot number for this recall is M254140.
The recall was initiated because faulty seals on the outer pouch of these double-pouched devices could result in seal failure. This defect poses a risk to the sterile integrity of the ophthalmic instruments.
The affected devices were distributed worldwide, including nationwide in the United States and in 21 other countries, including 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. Healthcare facilities and distributors should stop using the affected units and contact Synergetics for instructions on return or replacement.
The recalled product
- Product
- 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 24
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: M254140
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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