Synergetics Recalls 23ga Chandelier Infusion Cannulas Due to Seal Failure
Synergetics Inc is recalling 240 units of 23ga Chandelier Infusion Cannulas 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 criteria for a High severity score.
Plain-English summary
Synergetics Inc is recalling 240 units of 23ga Chandelier Infusion Cannulas, model 56.30.23P. The devices are sterile, single-use, ophthalmic instruments manufactured in O'Fallon, Missouri, and distributed worldwide, including the United States and 21 other countries.
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 sterility of the medical device.
The affected lot numbers are M260620, M265860, M267100, and M269230. Healthcare facilities and distributors should stop using these specific units and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 240
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 (4)
- Lot numbers: M260620
- M265860
- M267100
- and M269230
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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