CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
Chandelier Infusion Cannula, Synergetics, inc. recalled
Synergetics is recalling Chandelier Infusion Cannula, Synergetics, inc., length 7.5 ft, sterile / EO, 56.30.P, distributed nationwide in the US. The recall was initiated on 9 Dec 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0875-2014
- FDA event ID
- 67147
- Recalling firm
- Synergetics, O Fallon, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2013
- FDA classified
- 30 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 9 Dec 2013 | Recall initiated by company | |
| 30 Jan 2014 | Classified by FDA | +52 days |
| 5 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of 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.
Questions about this recall
Why was it recalled?
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Which lots are affected?
Lot number: M261320
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of 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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
27 other products · FDA event 67147This product is part of a recall event; the main page for the event is Chow Illuminated Pick, Synergetics, inc., length 7.5 ft recalled.
More recalls from Synergetics
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit Custom recalled by Synergetics | Synergetics | Sterility | Nationwide |
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit with Wire Speculum recalled | Synergetics | Sterility | Nationwide |
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit with Drape recalled by Synergetics | Synergetics | Sterility | Nationwide |
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit recalled by Synergetics | Synergetics | Sterility | Nationwide |
| Device | CLASS II | VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product recalled | Synergetics | Packaging Defects | 14 states |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |