Synergetics Chandelier Infusion Cannula Recalled for Faulty Seals
Synergetics Inc. is recalling Chandelier Infusion Cannulas due to faulty seals on the outer pouch, which could result in seal failure.
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 108 units of Chandelier Infusion Cannulas (20ga, 7.5 ft length) manufactured in O'Fallon, Missouri. The recall is due to faulty seals on the outer pouch of these double-pouched, single-use, sterile ophthalmic devices. The defect could result in seal failure.
The affected product is identified by lot number M261320. The devices were distributed worldwide, including the United States and various international markets such as 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.
Consumers and healthcare facilities should stop using the affected Chandelier Infusion Cannulas and contact Synergetics Inc. for further instructions or a return.
The recalled product
- Product
- Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 108
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: M261320
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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